What is NDC 67046-0446?

67046-0446 is the product NDC for Paroxetine, Paroxetine hydrochloride hemihydrate 40 mg/1 tablet, film coated, listed with the FDA by Coupler LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Paroxetine hydrochloride hemihydrate.

Coupler LLC, NDC labeler code 67046. 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 67046-0446 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)67046-0446Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67046-0446Add 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	Copy
67046-0446-3	6704604460367046044603	30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0446-3)Marketed from Aug 21, 2026

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 40 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Coupler LLCNDC labeler code 67046
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077584
Marketing start: Aug 21, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 67046-0446_598ecd94-6c5e-98fa-e063-6294a90aa3a4SPL ID 598ecd94-6c5e-98fa-e063-6294a90aa3a4SPL set ID 598ece4d-0ac4-993b-e063-6294a90a1d34RxCUI 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

N467046044603 followed by a unit qualifier and the quantity

Package 67046-0446-03. 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 Aug 21, 2026. 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 67046-0446

What is NDC 67046-0446?: 67046-0446 is the product NDC for Paroxetine, Paroxetine hydrochloride hemihydrate 40 mg/1 tablet, film coated, listed with the FDA by Coupler LLC. It has 1 package NDC, 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?: Coupler LLC, NDC labeler code 67046. 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 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
Paroxetineparoxetine hydrochloride hemihydrate	Paroxetine hydrochloride 20 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8777	68788-8777-0168788-8777-0368788-8777-06+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 20 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-0850
Paroxetine	Paroxetine hydrochloride 10 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-1297
Paroxetine	Paroxetine hydrochloride hemihydrate 20 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	55289-972
Paroxetine	Paroxetine hydrochloride hemihydrate 40 mg/1	Tablet, Film coatedOral	DIRECT RX	61919-513
Paroxetine	Paroxetine hydrochloride hemihydrate 20 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-105
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	Proficient Rx LP	63187-434
Paroxetine	Paroxetine hydrochloride hemihydrate 20 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-1840
Paroxetine	Paroxetine hydrochloride hemihydrate 40 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-3349
Paroxetineparoxetine hydrochloride	Paroxetine hydrochloride anhydrous 10 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	65841-097
Paroxetineparoxetine hydrochloride	Paroxetine hydrochloride anhydrous 20 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	65841-098
Paroxetineparoxetine hydrochloride	Paroxetine hydrochloride anhydrous 30 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	65841-099
Paroxetineparoxetine hydrochloride	Paroxetine hydrochloride anhydrous 40 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	65841-601
Paroxetine	Paroxetine hydrochloride hemihydrate 30 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0846
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	NuCare Pharamceuticals, Inc.	68071-2535
Paroxetine	Paroxetine hydrochloride 10 mg/1	Tablet, Film coatedOral	American Health Packaging	68084-044
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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