NDC 50580-726OTC monographFDA NDA · NDA019835

Zyrtec Allergy

Active substance: Cetirizine Hydrochloride

15 formulations • 50 package configurations

All 65 registered NDCs — click to copy

In one line

Zyrtec Allergy (Cetirizine Hydrochloride) NDC 50580-726 converts to 50580-0726-03 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: 50580-726 Verified

1. Initial Approval

2008

First U.S. FDA clearance for Cetirizine Hydrochloride

2. FDA Application

NDA019835

Regulatory pathway: NDA

3. Market Entry Date

Jan 1, 2008

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

50580-0726-03

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 Zyrtec Allergy, with 10-digit and 11-digit NDC formats
Formulation / role	Package NDC	Product NDC	11-digit HIPAA	Packaging detail
10 mg/1	73097-016-20	73097-016	73097-0016-20	20 POUCH in 1 CARTON (73097-016-20) / 1 TABLET, FILM COATED in 1 POUCH
5 mg/5mL	50580-721-05	50580-721	50580-0721-05	1 BOTTLE, PLASTIC in 1 CARTON (50580-721-05) / 118 mL in 1 BOTTLE, PLASTIC
10 mg/1	50580-726-03	50580-726	50580-0726-03	50 BLISTER PACK in 1 CARTON (50580-726-03) / 1 TABLET, FILM COATED in 1 BLISTER PACK
10 mg/1	50580-726-05	50580-726	50580-0726-05	50 POUCH in 1 CARTON (50580-726-05) / 1 TABLET, FILM COATED in 1 POUCH
10 mg/1	50580-726-25	50580-726	50580-0726-25	2500 POUCH in 1 CASE (50580-726-25) / 1 TABLET, FILM COATED in 1 POUCH
10 mg/1	50580-726-36	50580-726	50580-0726-36	1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-36) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
10 mg/1	50580-726-40	50580-726	50580-0726-40	1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-40) / 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
10 mg/1	50580-726-45	50580-726	50580-0726-45	1 BOTTLE in 1 CARTON (50580-726-45) / 45 TABLET, FILM COATED in 1 BOTTLE
10 mg/1	50580-726-50	50580-726	50580-0726-50	1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
10 mg/1	50580-726-66	50580-726	50580-0726-66	75 TABLET, FILM COATED in 1 PACKAGE, COMBINATION (50580-726-66)
10 mg/1	50580-726-70	50580-726	50580-0726-70	1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-70) / 70 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
10 mg/1	50580-726-71	50580-726	50580-0726-71	1 BOTTLE in 1 CARTON (50580-726-71) / 30 TABLET, FILM COATED in 1 BOTTLE
10 mg/1	50580-726-72	50580-726	50580-0726-72	1 BOTTLE in 1 CARTON (50580-726-72) / 40 TABLET, FILM COATED in 1 BOTTLE
10 mg/1	50580-726-73	50580-726	50580-0726-73	1 BOTTLE in 1 CARTON (50580-726-73) / 60 TABLET, FILM COATED in 1 BOTTLE
10 mg/1	50580-726-74	50580-726	50580-0726-74	1 BOTTLE in 1 CARTON (50580-726-74) / 90 TABLET, FILM COATED in 1 BOTTLE
10 mg/1	50580-726-75	50580-726	50580-0726-75	1 BOTTLE in 1 CARTON (50580-726-75) / 75 TABLET, FILM COATED in 1 BOTTLE
10 mg/1	50580-726-90	50580-726	50580-0726-90	2 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-90) / 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
10 mg/1	50580-726-91	50580-726	50580-0726-91	2500 POUCH in 1 CARTON (50580-726-91) / 1 TABLET, FILM COATED in 1 POUCH
10 mg/1	50580-726-92	50580-726	50580-0726-92	50 POUCH in 1 TRAY (50580-726-92) / 1 TABLET, FILM COATED in 1 POUCH
10 mg/1	50580-726-93	50580-726	50580-0726-93	3 POUCH in 1 CARTON (50580-726-93) / 1 TABLET, FILM COATED in 1 POUCH
10 mg/1	50580-726-94	50580-726	50580-0726-94	1 BOTTLE in 1 PACKAGE (50580-726-94) / 60 TABLET, FILM COATED in 1 BOTTLE
10 mg/1	50580-726-95	50580-726	50580-0726-95	1 BOTTLE in 1 PACKAGE (50580-726-95) / 90 TABLET, FILM COATED in 1 BOTTLE
10 mg/1	50580-726-96	50580-726	50580-0726-96	5 POUCH in 1 CARTON (50580-726-96) / 1 TABLET, FILM COATED in 1 POUCH
10 mg/1	50580-726-97	50580-726	50580-0726-97	14 POUCH in 1 CARTON (50580-726-97) / 1 TABLET, FILM COATED in 1 POUCH
Outer kit carton	50580-752-01	50580-752	50580-0752-01	1 KIT in 1 PACKAGE (50580-752-01) * 1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC * 1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-70) / 70 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
5 mg/1	50580-754-15	50580-754	50580-0754-15	15 POUCH in 1 CARTON (50580-754-15) / 1 TABLET, FILM COATED in 1 POUCH
5 mg/1	50580-754-35	50580-754	50580-0754-35	1 BOTTLE in 1 CARTON (50580-754-35) / 35 TABLET, FILM COATED in 1 BOTTLE
10 mg/1	50580-778-24	50580-778	50580-0778-24	4 BLISTER PACK in 1 CARTON (50580-778-24) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
10 mg/1	50580-782-01	50580-782	50580-0782-01	2 CARTON in 1 PACKAGE (50580-782-01) / 4 BLISTER PACK in 1 CARTON / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
10 mg/1	50580-782-12	50580-782	50580-0782-12	2 BLISTER PACK in 1 CARTON (50580-782-12) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
10 mg/1	50580-782-24	50580-782	50580-0782-24	4 BLISTER PACK in 1 CARTON (50580-782-24) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
10 mg/1	85237-2960-1	85237-2960	85237-2960-01	1 POUCH in 1 BLISTER PACK (85237-2960-1) / 1 TABLET, FILM COATED in 1 POUCH (85237-2960-0)
Inner component	85237-2960-0	85237-2960	85237-2960-00	Inner component of kit (85237-2960-1)
10 mg/1	85237-2960-3	85237-2960	85237-2960-03	20 POUCH in 1 CARTON (85237-2960-3) / 1 TABLET, FILM COATED in 1 POUCH (85237-2960-0)
10 mg/1	50580-786-12	50580-786	50580-0786-12	1 BOTTLE in 1 PACKAGE (50580-786-12) / 12 CAPSULE, LIQUID FILLED in 1 BOTTLE
10 mg/1	50580-786-13	50580-786	50580-0786-13	1 BOTTLE in 1 CARTON (50580-786-13) / 12 CAPSULE, LIQUID FILLED in 1 BOTTLE
10 mg/1	50580-786-25	50580-786	50580-0786-25	1 BOTTLE in 1 PACKAGE (50580-786-25) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE
10 mg/1	50580-786-26	50580-786	50580-0786-26	1 BOTTLE in 1 CARTON (50580-786-26) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE
10 mg/1	50580-786-40	50580-786	50580-0786-40	1 BOTTLE in 1 PACKAGE (50580-786-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE
10 mg/1	50580-786-41	50580-786	50580-0786-41	1 BOTTLE in 1 CARTON (50580-786-41) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE
10 mg/1	50580-786-65	50580-786	50580-0786-65	65 CAPSULE, LIQUID FILLED in 1 PACKAGE, COMBINATION (50580-786-65)
10 mg/1	50580-786-66	50580-786	50580-0786-66	65 CAPSULE, LIQUID FILLED in 1 PACKAGE (50580-786-66)
10 mg/1	67296-1484-3	67296-1484	67296-1484-03	30 TABLET, FILM COATED in 1 BOTTLE (67296-1484-3)
10 mg/1	66715-9811-1	66715-9811	66715-9811-01	1 POUCH in 1 CARTON (66715-9811-1) / 1 TABLET, FILM COATED in 1 POUCH
10 mg/1	67414-012-00	67414-012	67414-0012-00	1 BOTTLE in 1 CARTON (67414-012-00) / 90 CAPSULE in 1 BOTTLE
10 mg/1	67414-013-01	67414-013	67414-0013-01	1 BOTTLE in 1 CARTON (67414-013-01) / 12 CAPSULE in 1 BOTTLE
10 mg/1	67414-013-02	67414-013	67414-0013-02	1 BOTTLE in 1 CARTON (67414-013-02) / 25 CAPSULE in 1 BOTTLE
10 mg/1	67414-013-03	67414-013	67414-0013-03	1 BOTTLE in 1 CARTON (67414-013-03) / 40 CAPSULE in 1 BOTTLE
10 mg/1	53209-5001-1	53209-5001	53209-5001-01	1 TABLET, FILM COATED in 1 BLISTER PACK (53209-5001-1)
10 mg/1	67751-192-01	67751-192	67751-0192-01	1 POUCH in 1 CARTON (67751-192-01) / 1 TABLET, FILM COATED in 1 POUCH

Taken from the manufacturer's FDA Structured Product Labeling submission. This is the label as filed, not a summary.

3 Label Sections

INDICATIONS AND USAGE

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

DOSAGE AND ADMINISTRATION

Directions adults and children 6 years and over one 10 mg capsule once daily; do not take more than one 10 mg capsule in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

WARNINGS AND PRECAUTIONS

Warnings Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding if breast-feeding: not recommended if pregnant: ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Pharmacologic class

Histamine H1 Receptor Antagonists

Every other National Drug Code registered in the same established class.

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FDA Approval & Market Entry Timeline

NDC • HCPCS Level II • CPT administration

All registered strengths & packaging

Prescribing information

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Histamine H1 Receptor Antagonists