What is NDC 76420-716?

76420-716 is the product NDC for Paroxetine, Paroxetine hydrochloride hemihydrate 10 mg/1 tablet, film coated, listed with the FDA by Asclemed USA, Inc.. It has 6 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Paroxetine hydrochloride hemihydrate.

Asclemed USA, Inc., NDC labeler code 76420. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Paroxetine?

145 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Paroxetine NDC 76420-716 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)76420-716Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76420-0716Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
76420-716-01	7642007160176420071601	100 TABLET, FILM COATED in 1 BOTTLE (76420-716-01)Marketed from May 6, 2024
76420-716-05	7642007160576420071605	500 TABLET, FILM COATED in 1 BOTTLE (76420-716-05)Marketed from May 6, 2024
76420-716-10	7642007161076420071610	1000 TABLET, FILM COATED in 1 BOTTLE (76420-716-10)Marketed from May 6, 2024
76420-716-30	7642007163076420071630	30 TABLET, FILM COATED in 1 BOTTLE (76420-716-30)Marketed from May 6, 2024
76420-716-60	7642007166076420071660	60 TABLET, FILM COATED in 1 BOTTLE (76420-716-60)Marketed from May 6, 2024
76420-716-90	7642007169076420071690	90 TABLET, FILM COATED in 1 BOTTLE (76420-716-90)Marketed from May 6, 2024

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Paroxetine
Generic name (nonproprietary): paroxetine
Active ingredients: Paroxetine hydrochloride hemihydrate — 10 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Asclemed USA, Inc.NDC labeler code 76420
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077584
Marketing start: Apr 13, 2007
Listing expires: Dec 31, 2027
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 76420-716_2e000f86-0592-a362-e063-6394a90a169dSPL ID 2e000f86-0592-a362-e063-6394a90a169dSPL set ID 4acd3e7a-4f19-4428-9452-48ce370cb3dbRxCUI 1738483, 1738495, 1738503, 1738511UNII X2ELS050D8
Pharmacologic class: Serotonin Reuptake Inhibitor

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N476420071601 followed by a unit qualifier and the quantity

Package 76420-0716-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Feb 13, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Paroxetine tablets are indicated in adults for the treatment of: Major depressive disorder (MDD) Obsessive compulsive disorder (OCD) Panic disorder (PD) Social anxiety disorder (SAD) Generalized anxiety disorder (GAD) Posttraumatic stress disorder (PTSD) Paroxetine is a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of ( 1 ): Major Depressive Disorder (MDD) Obsessive Compulsive Disorder (OCD) Panic Disorder (PD) Social Anxiety Disorder (SAD) Generalized Anxiety Disorder (GAD) Posttraumatic Stress Disorder (PTSD)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76420-716

What is NDC 76420-716?: 76420-716 is the product NDC for Paroxetine, Paroxetine hydrochloride hemihydrate 10 mg/1 tablet, film coated, listed with the FDA by Asclemed USA, Inc.. It has 6 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Paroxetine.
What is the active ingredient?: Paroxetine hydrochloride hemihydrate.
Who is the labeler?: Asclemed USA, Inc., NDC labeler code 76420. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Paroxetine?: 145 other product NDCs are listed under this name. See all Paroxetine NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Paroxetine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Paroxetineparoxetine hydrochloride hemihydrate	Paroxetine hydrochloride 20 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4130	68788-4130-0168788-4130-0368788-4130-06+2 more
Paroxetine	Paroxetine hydrochloride hemihydrate 40 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0446	67046-0446-03
Paroxetine	Paroxetine hydrochloride hemihydrate 30 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0846	67046-0846-03
Paroxetine	Paroxetine hydrochloride hemihydrate 12.5 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Limited	46708-766	46708-0766-3046708-0766-91
Paroxetine	Paroxetine hydrochloride hemihydrate 12.5 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Inc.	62332-766	62332-0766-3062332-0766-91
Paroxetine	Paroxetine hydrochloride hemihydrate 25 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Limited	46708-767	46708-0767-3046708-0767-91
Paroxetine	Paroxetine hydrochloride hemihydrate 37.5 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Limited	46708-768	46708-0768-3046708-0768-91
Paroxetine	Paroxetine hydrochloride hemihydrate 25 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Inc.	62332-767	62332-0767-3062332-0767-91
Paroxetine	Paroxetine hydrochloride hemihydrate 37.5 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Inc.	62332-768	62332-0768-3062332-0768-91
Paroxetineparoxetine hydrochloride hemihydrate	Paroxetine hydrochloride 10 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8829	68788-8829-0168788-8829-0368788-8829-06+2 more

All 146 Paroxetine NDCs

Other NDCs under ANDA 077584

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 077584
Product	Strength	Form · route	Labeler	Product NDC
Paroxetine	Paroxetine hydrochloride 10 mg/1	Tablet, Film coatedOral	American Health Packaging	68084-044
Paroxetine	Paroxetine hydrochloride 40 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-6870
Paroxetine	Paroxetine hydrochloride hemihydrate 10 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-1740
Paroxetine	Paroxetine hydrochloride hemihydrate 10 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-190
Paroxetine	Paroxetine hydrochloride hemihydrate 40 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-3349
Paroxetine	Paroxetine hydrochloride 20 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-0850
Paroxetine	Paroxetine hydrochloride hemihydrate 40 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0446
Paroxetineparoxetine hydrochloride	Paroxetine hydrochloride 10 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals, Inc	68788-0797
Paroxetine	Paroxetine hydrochloride hemihydrate 20 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-717
Paroxetine	Paroxetine hydrochloride hemihydrate 30 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-718
Paroxetine	Paroxetine hydrochloride hemihydrate 30 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0321
Paroxetine	Paroxetine hydrochloride hemihydrate 40 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-719
Paroxetine	Paroxetine hydrochloride 30 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-7410
Paroxetine	Paroxetine hydrochloride 10 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-1297
Paroxetine	Paroxetine hydrochloride hemihydrate 40 mg/1	Tablet, Film coatedOral	DIRECT RX	61919-513
Paroxetine	Paroxetine hydrochloride hemihydrate 40 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-434
Paroxetine	Paroxetine hydrochloride hemihydrate 30 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-2465
Paroxetine	Paroxetine hydrochloride 20 mg/1	Tablet, Film coatedOral	American Health Packaging	68084-045
Paroxetine	Paroxetine hydrochloride 30 mg/1	Tablet, Film coatedOral	American Health Packaging	68084-046
Paroxetine	Paroxetine hydrochloride 40 mg/1	Tablet, Film coatedOral	American Health Packaging	68084-047

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