What is NDC 46708-766?

46708-766 is the product NDC for Paroxetine, Paroxetine hydrochloride hemihydrate 12.5 mg/1 tablet, film coated, extended release, listed with the FDA by Alembic Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Paroxetine hydrochloride hemihydrate.

Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 46708-766 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-766Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0766Add 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
46708-766-30	4670807663046708076630	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-766-30)Marketed from Mar 31, 2026
46708-766-91	4670807669146708076691	1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-766-91)Marketed from Mar 31, 2026

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 — 12.5 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217280
Marketing start: Mar 31, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 46708-766_e7609c36-21f5-42e2-8d74-ddaf8f94233fSPL ID e7609c36-21f5-42e2-8d74-ddaf8f94233fSPL set ID 59cb7de6-483d-4007-b6ef-f10a70b872e9RxCUI 1738803, 1738805, 1738807UNII X2ELS050D8UPC 0346708768300
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

N446708076630 followed by a unit qualifier and the quantity

Package 46708-0766-30. 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 Apr 3, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Paroxetine extended-release tablets are indicated in adults for the treatment of: • Major depressive disorder (MDD) • Panic disorder (PD) • Social anxiety disorder (SAD) • Premenstrual dysphoric disorder (PMDD) Paroxetine extended-release tablets are selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of (1): • Major Depressive Disorder (MDD) • Panic Disorder (PD) • Social Anxiety Disorder (SAD) • Premenstrual Dysphoric Disorder (PMDD)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 46708-766

What is NDC 46708-766?: 46708-766 is the product NDC for Paroxetine, Paroxetine hydrochloride hemihydrate 12.5 mg/1 tablet, film coated, extended release, listed with the FDA by Alembic Pharmaceuticals Limited. It has 2 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?: Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 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 217280

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

FDA NDC Directory listings under ANDA 217280
Product	Strength	Form · route	Labeler	Product NDC
Paroxetine	Paroxetine hydrochloride hemihydrate 25 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Limited	46708-767
Paroxetine	Paroxetine hydrochloride hemihydrate 37.5 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Limited	46708-768
Paroxetine	Paroxetine hydrochloride hemihydrate 12.5 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Inc.	62332-766
Paroxetine	Paroxetine hydrochloride hemihydrate 25 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Inc.	62332-767
Paroxetine	Paroxetine hydrochloride hemihydrate 37.5 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Inc.	62332-768