NDC 65862-611OTC monographFDA BULK INGREDIENT

Generic formulation

Active substance: Entacapone

44 formulations • 68 package configurations

All 112 registered NDCs — click to copy

In one line

Generic formulation (Entacapone) NDC 65862-611 converts to 65862-0611-37 for billing. It is dispensed by a pharmacy and billed directly on the NDC — no HCPCS J-code is required.

FDA Approval & Market Entry Timeline

Official openFDA & DailyMed regulatory registration sequence

Listing: 65862-611 Verified

1. Initial Approval

2023

First U.S. FDA clearance for Entacapone

2. FDA Application

BULK INGREDIENT

Regulatory pathway: BULK INGREDIENT

3. Market Entry Date

Jan 11, 2024

First commercial NDC distribution & launch date

4. Regulatory Status

Active Commercial Listing

Registration valid through Dec 31, 2026

Billing & reimbursement crosswalk

NDC • HCPCS Level II • CPT administration

Reimbursement channel

NDC direct

Oral / Topical formulation billed directly via 11-Digit NDC (No HCPCS J-Code required).

Standard pharmacy claim — no J-Code required

11-digit HIPAA NDC

65862-0611-37

Zero-padded 5-4-2 format

Standard conversion

CPT administration code

Self-Administered (Oral)

Dispensed via retail/mail pharmacy. No clinical administration procedure (CPT) required.

UB-04 revenue code

Rev 0250

0250 (General Pharmacy)

Qualifier: UN

Always verify NDC package code, billable multiplier, and invoice qualifier with specific payer guidelines before claim filing.

Every registered strength and package for Generic formulation, with 10-digit and 11-digit NDC formats
Formulation / role	Package NDC	Product NDC	11-digit HIPAA	Packaging detail
18.75 mg/1, 75 mg/1, 200 mg/1	0781-5625-01	0781-5625	00781-5625-01	100 TABLET, FILM COATED in 1 BOTTLE (0781-5625-01)
200 mg/1	0527-1830-37	0527-1830	00527-1830-37	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1830-37)
12.5 mg/1, 50 mg/1, 200 mg/1	62332-795-31	62332-795	62332-0795-31	100 TABLET, FILM COATED in 1 BOTTLE (62332-795-31)
12.5 mg/1, 50 mg/1, 200 mg/1	62332-795-91	62332-795	62332-0795-91	1000 TABLET, FILM COATED in 1 BOTTLE (62332-795-91)
18.75 mg/1, 75 mg/1, 200 mg/1	62332-796-31	62332-796	62332-0796-31	100 TABLET, FILM COATED in 1 BOTTLE (62332-796-31)
18.75 mg/1, 75 mg/1, 200 mg/1	62332-796-91	62332-796	62332-0796-91	1000 TABLET, FILM COATED in 1 BOTTLE (62332-796-91)
25 mg/1, 100 mg/1, 200 mg/1	62332-797-31	62332-797	62332-0797-31	100 TABLET, FILM COATED in 1 BOTTLE (62332-797-31)
25 mg/1, 100 mg/1, 200 mg/1	62332-797-91	62332-797	62332-0797-91	1000 TABLET, FILM COATED in 1 BOTTLE (62332-797-91)
31.25 mg/1, 125 mg/1, 200 mg/1	62332-798-31	62332-798	62332-0798-31	100 TABLET, FILM COATED in 1 BOTTLE (62332-798-31)
31.25 mg/1, 125 mg/1, 200 mg/1	62332-798-91	62332-798	62332-0798-91	1000 TABLET, FILM COATED in 1 BOTTLE (62332-798-91)
37.5 mg/1, 150 mg/1, 200 mg/1	62332-799-31	62332-799	62332-0799-31	100 TABLET, FILM COATED in 1 BOTTLE (62332-799-31)
37.5 mg/1, 150 mg/1, 200 mg/1	62332-799-91	62332-799	62332-0799-91	1000 TABLET, FILM COATED in 1 BOTTLE (62332-799-91)
200 mg/1	0781-5578-01	0781-5578	00781-5578-01	100 TABLET, FILM COATED in 1 BOTTLE (0781-5578-01)
50 mg/1, 200 mg/1, 200 mg/1	62332-800-31	62332-800	62332-0800-31	100 TABLET, FILM COATED in 1 BOTTLE (62332-800-31)
50 mg/1, 200 mg/1, 200 mg/1	62332-800-91	62332-800	62332-0800-91	1000 TABLET, FILM COATED in 1 BOTTLE (62332-800-91)
12.5 mg/1, 50 mg/1, 200 mg/1	0781-5613-01	0781-5613	00781-5613-01	100 TABLET, FILM COATED in 1 BOTTLE (0781-5613-01)
25 mg/1, 100 mg/1, 200 mg/1	0781-5637-01	0781-5637	00781-5637-01	100 TABLET, FILM COATED in 1 BOTTLE (0781-5637-01)
200 mg/1	62332-478-31	62332-478	62332-0478-31	100 TABLET, FILM COATED in 1 BOTTLE (62332-478-31)
200 mg/1	62332-478-91	62332-478	62332-0478-91	1000 TABLET, FILM COATED in 1 BOTTLE (62332-478-91)
12.5 mg/1, 50 mg/1, 200 mg/1	16571-689-01	16571-689	16571-0689-01	100 TABLET, FILM COATED in 1 BOTTLE (16571-689-01)
18.75 mg/1, 75 mg/1, 200 mg/1	16571-690-01	16571-690	16571-0690-01	100 TABLET, FILM COATED in 1 BOTTLE (16571-690-01)
25 mg/1, 100 mg/1, 200 mg/1	16571-691-01	16571-691	16571-0691-01	100 TABLET, FILM COATED in 1 BOTTLE (16571-691-01)
31.25 mg/1, 125 mg/1, 200 mg/1	0781-5641-01	0781-5641	00781-5641-01	100 TABLET, FILM COATED in 1 BOTTLE (0781-5641-01)
31.25 mg/1, 125 mg/1, 200 mg/1	16571-692-01	16571-692	16571-0692-01	100 TABLET, FILM COATED in 1 BOTTLE (16571-692-01)
37.5 mg/1, 150 mg/1, 200 mg/1	16571-693-01	16571-693	16571-0693-01	100 TABLET, FILM COATED in 1 BOTTLE (16571-693-01)
50 mg/1, 200 mg/1, 200 mg/1	16571-694-01	16571-694	16571-0694-01	100 TABLET, FILM COATED in 1 BOTTLE (16571-694-01)
200 mg/1	33342-260-11	33342-260	33342-0260-11	100 TABLET in 1 BOTTLE (33342-260-11)
200 mg/1	33342-260-15	33342-260	33342-0260-15	500 TABLET in 1 BOTTLE (33342-260-15)
37.5 mg/1, 150 mg/1, 200 mg/1	0781-5654-01	0781-5654	00781-5654-01	100 TABLET, FILM COATED in 1 BOTTLE (0781-5654-01)
200 mg/1	50268-295-15	50268-295	50268-0295-15	50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-295-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-295-11)
Inner component	50268-295-11	50268-295	50268-0295-11	Inner component of kit (50268-295-15)
12.5 mg/1, 50 mg/1, 200 mg/1	46708-795-31	46708-795	46708-0795-31	100 TABLET, FILM COATED in 1 BOTTLE (46708-795-31)
12.5 mg/1, 50 mg/1, 200 mg/1	46708-795-91	46708-795	46708-0795-91	1000 TABLET, FILM COATED in 1 BOTTLE (46708-795-91)
18.75 mg/1, 75 mg/1, 200 mg/1	46708-796-31	46708-796	46708-0796-31	100 TABLET, FILM COATED in 1 BOTTLE (46708-796-31)
18.75 mg/1, 75 mg/1, 200 mg/1	46708-796-91	46708-796	46708-0796-91	1000 TABLET, FILM COATED in 1 BOTTLE (46708-796-91)
25 mg/1, 100 mg/1, 200 mg/1	46708-797-31	46708-797	46708-0797-31	100 TABLET, FILM COATED in 1 BOTTLE (46708-797-31)
25 mg/1, 100 mg/1, 200 mg/1	46708-797-91	46708-797	46708-0797-91	1000 TABLET, FILM COATED in 1 BOTTLE (46708-797-91)
31.25 mg/1, 125 mg/1, 200 mg/1	46708-798-31	46708-798	46708-0798-31	100 TABLET, FILM COATED in 1 BOTTLE (46708-798-31)
31.25 mg/1, 125 mg/1, 200 mg/1	46708-798-91	46708-798	46708-0798-91	1000 TABLET, FILM COATED in 1 BOTTLE (46708-798-91)
37.5 mg/1, 150 mg/1, 200 mg/1	46708-799-31	46708-799	46708-0799-31	100 TABLET, FILM COATED in 1 BOTTLE (46708-799-31)
37.5 mg/1, 150 mg/1, 200 mg/1	46708-799-91	46708-799	46708-0799-91	1000 TABLET, FILM COATED in 1 BOTTLE (46708-799-91)
50 mg/1, 200 mg/1, 200 mg/1	46708-800-31	46708-800	46708-0800-31	100 TABLET, FILM COATED in 1 BOTTLE (46708-800-31)
50 mg/1, 200 mg/1, 200 mg/1	46708-800-91	46708-800	46708-0800-91	1000 TABLET, FILM COATED in 1 BOTTLE (46708-800-91)
200 mg/1	65862-654-01	65862-654	65862-0654-01	100 TABLET, FILM COATED in 1 BOTTLE (65862-654-01)
200 mg/1	65862-654-99	65862-654	65862-0654-99	1000 TABLET, FILM COATED in 1 BOTTLE (65862-654-99)
50 mg/1, 200 mg/1, 200 mg/1	0781-5669-01	0781-5669	00781-5669-01	100 TABLET, FILM COATED in 1 BOTTLE (0781-5669-01)
200 mg/1	0615-8298-39	0615-8298	00615-8298-39	30 TABLET in 1 BLISTER PACK (0615-8298-39)
200 mg/1	0904-6822-07	0904-6822	00904-6822-07	30 BLISTER PACK in 1 CARTON (0904-6822-07) / 1 TABLET, FILM COATED in 1 BLISTER PACK
200 mg/1	46708-478-31	46708-478	46708-0478-31	100 TABLET, FILM COATED in 1 BOTTLE (46708-478-31)
200 mg/1	46708-478-91	46708-478	46708-0478-91	1000 TABLET, FILM COATED in 1 BOTTLE (46708-478-91)
200 mg/1	47335-007-88	47335-007	47335-0007-88	100 TABLET, FILM COATED in 1 BOTTLE (47335-007-88)
200 mg/1	27241-049-10	27241-049	27241-0049-10	100 TABLET in 1 BOTTLE (27241-049-10)
200 mg/1	64980-722-01	64980-722	64980-0722-01	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-722-01)
200 mg/1	71610-247-83	71610-247	71610-0247-83	3600 TABLET, FILM COATED in 1 BOTTLE (71610-247-83)
12.5 mg/1, 50 mg/1, 200 mg/1	33342-491-11	33342-491	33342-0491-11	100 TABLET, FILM COATED in 1 BOTTLE (33342-491-11)
12.5 mg/1, 50 mg/1, 200 mg/1	33342-491-12	33342-491	33342-0491-12	10 BLISTER PACK in 1 CARTON (33342-491-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK
200 mg/1	60687-188-21	60687-188	60687-0188-21	30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-188-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-188-11)
Inner component	60687-188-11	60687-188	60687-0188-11	Inner component of kit (60687-188-21)
18.75 mg/1, 75 mg/1, 200 mg/1	33342-492-11	33342-492	33342-0492-11	100 TABLET, FILM COATED in 1 BOTTLE (33342-492-11)
18.75 mg/1, 75 mg/1, 200 mg/1	33342-492-12	33342-492	33342-0492-12	10 BLISTER PACK in 1 CARTON (33342-492-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK
25 mg/1, 100 mg/1, 200 mg/1	33342-493-11	33342-493	33342-0493-11	100 TABLET, FILM COATED in 1 BOTTLE (33342-493-11)
25 mg/1, 100 mg/1, 200 mg/1	33342-493-12	33342-493	33342-0493-12	10 BLISTER PACK in 1 CARTON (33342-493-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK
31.25 mg/1, 125 mg/1, 200 mg/1	33342-494-11	33342-494	33342-0494-11	100 TABLET, FILM COATED in 1 BOTTLE (33342-494-11)
31.25 mg/1, 125 mg/1, 200 mg/1	33342-494-12	33342-494	33342-0494-12	10 BLISTER PACK in 1 CARTON (33342-494-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK
37.5 mg/1, 150 mg/1, 200 mg/1	33342-495-11	33342-495	33342-0495-11	100 TABLET, FILM COATED in 1 BOTTLE (33342-495-11)
37.5 mg/1, 150 mg/1, 200 mg/1	33342-495-12	33342-495	33342-0495-12	10 BLISTER PACK in 1 CARTON (33342-495-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK
50 mg/1, 200 mg/1, 200 mg/1	33342-496-11	33342-496	33342-0496-11	100 TABLET, FILM COATED in 1 BOTTLE (33342-496-11)
50 mg/1, 200 mg/1, 200 mg/1	33342-496-12	33342-496	33342-0496-12	10 BLISTER PACK in 1 CARTON (33342-496-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Taken from the manufacturer's FDA Structured Product Labeling submission. This is the label as filed, not a summary. Initial U.S. approval: 2023.

Highlights

These highlights do not include all the information needed to use Generic formulation safely and effectively. The full sections follow.

Indications and usage: AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in: • Individuals 60 years of age and older. • Individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. Limitations of Use: AREXVY is not for use in pregnant individuals.
Dosage and administration: For intramuscular use only. • After reconstitution, a single dose of AREXVY is either 0.5 mL (vial and vial presentation) or approximately 0.5 mL (vial and prefilled syringe presentation). • Supplied as two presentations: (1) Vial of Lyophilized Antigen Component reconstituted with accompanying Adjuvant Suspension Component vial; (2) Vial of Lyophilized Antigen Component reconstituted with accompanying prefilled syringe of Adjuvant Suspension Component.
Dosage forms and strengths: For injectable suspension: Single dose after reconstitution is 0.5 mL (vial/vial) or approximately 0.5 mL (vial/prefilled syringe).
Contraindications: History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.
Warnings and precautions: • Guillain-Barré Syndrome: Postmarketing observational study suggests an increased risk of Guillain-Barré syndrome during the 42 days following vaccination. • Allergic Reactions: Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions. • Syncope: Syncope (fainting) may occur; procedures should be in place to avoid injury from falling. • Altered Immunocompetence: Immunocompromised persons may have a diminished immune response.
Adverse reactions: • Most commonly reported adverse reactions (≥10%) in adults ≥60 years: injection site pain (60.9%), fatigue (33.6%), myalgia (28.9%), headache (27.2%), and arthralgia (18.1%). • In adults 50–59 years: injection site pain (75.8%), fatigue (39.8%), myalgia (35.6%), headache (31.7%), arthralgia (23.4%), erythema (13.2%), and swelling (10.4%). • In adults 18–49 years: injection site pain (76.0%), myalgia (59.9%), fatigue (59.6%), headache (43.6%), and arthralgia (28.3%).

13 Label Sections

INDICATIONS AND USAGE

AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in: • Individuals 60 years of age and older. • Individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. Limitations of Use: AREXVY is not for use in pregnant individuals [see Use in Specific Populations (8.1)].

DOSAGE AND ADMINISTRATION

2.1 Dose and Schedule After reconstitution, a single dose of AREXVY is either 0.5 mL (vial and vial presentation) or approximately 0.5 mL (vial and prefilled syringe presentation). 2.2 Preparation & Reconstitution Instructions AREXVY is supplied in two presentations that must be combined prior to administration: • Vial and Vial Presentation: Reconstitute the Lyophilized Antigen Component (sterile white powder) with the accompanying Adjuvant Suspension Component (opalescent, colorless to pale brownish liquid). Use only the supplied Adjuvant Suspension Component for reconstitution. Withdraw entire contents of adjuvant vial and slowly transfer into antigen powder vial. Gently swirl until completely dissolved. • Vial and Prefilled Syringe Presentation: Reconstitute the Lyophilized Antigen Component vial with the accompanying prefilled syringe of Adjuvant Suspension Component. Slowly transfer entire contents into antigen vial and gently swirl until powder dissolves. 2.3 Administration For intramuscular (IM) injection only, preferably in the deltoid region. After reconstitution, administer AREXVY immediately or store protected from light in the refrigerator between 2°C and 8°C (36°F to 46°F) or at room temperature [up to 25°C (77°F)] and use within 4 hours. Discard reconstituted vaccine if not used within 4 hours.

DOSAGE FORMS AND STRENGTHS

For injectable suspension. • For the vial and vial presentation, a single dose after reconstitution is 0.5 mL. • For the vial and prefilled syringe presentation, a single dose after reconstitution is approximately 0.5 mL.

CONTRAINDICATIONS

Do not administer AREXVY to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of AREXVY [see Description (11)].

WARNINGS AND PRECAUTIONS

5.1 Guillain-Barré Syndrome The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination with AREXVY [see Adverse Reactions (6.2)]. 5.2 Preventing and Managing Allergic Reactions Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of AREXVY. 5.3 Syncope Syncope (fainting) may occur in association with administration of injectable vaccines, including AREXVY. Procedures should be in place to avoid injury from fainting. 5.4 Altered Immunocompetence Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to AREXVY.

ADVERSE REACTIONS

6.1 Clinical Trials Experience The safety of AREXVY was evaluated in over 17,879 vaccine recipients in multi-center clinical trials (Study 1: NCT04886596 in 24,966 participants). Most Commonly Reported Solicited Adverse Reactions: • Adults ≥60 years: Injection site pain (60.9%), Fatigue (33.6%), Myalgia (28.9%), Headache (27.2%), Arthralgia (18.1%), Erythema (7.5%), Swelling (5.5%), Fever (2.0%). • Adults 50–59 years: Injection site pain (75.8%), Fatigue (39.8%), Myalgia (35.6%), Headache (31.7%), Arthralgia (23.4%), Erythema (13.2%), Swelling (10.4%). • Adults 18–49 years: Injection site pain (76.0%), Myalgia (59.9%), Fatigue (59.6%), Headache (43.6%), Arthralgia (28.3%). 6.2 Postmarketing Experience Postmarketing surveillance identified cases of Guillain-Barré syndrome and acute hypersensitivity reactions following administration.

DRUG INTERACTIONS & CONCOMITANT ADMINISTRATION

USE IN SPECIFIC POPULATIONS

DESCRIPTION

CLINICAL PHARMACOLOGY

CLINICAL STUDIES

HOW SUPPLIED / STORAGE AND HANDLING

AREXVY is supplied as: • Outer Carton Kit (58160-848-11): 1 vial of Lyophilized Antigen Component (58160-723-03) and 1 vial of Adjuvant Suspension Component (58160-744-03). • Outer Carton Kit (58160-894-15): 1 vial of Lyophilized Antigen Component (58160-719-03) and 1 prefilled syringe of Adjuvant Suspension Component (58160-749-07). • Outer Carton Kit (58160-882-12): 1 vial of Lyophilized Antigen Component (58160-719-03) and 1 prefilled syringe of Adjuvant Suspension Component (58160-749-07). Storage before Reconstitution: Store in refrigerator between 2°C and 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. Discard if frozen. Storage after Reconstitution: Use immediately or store in refrigerator at 2°C to 8°C or room temperature up to 25°C (77°F) for up to 4 hours.

PATIENT COUNSELING INFORMATION

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