What is NDC 63629-8527?

63629-8527 is the product NDC for Paroxetine Hydrochloride, Paroxetine hydrochloride hemihydrate 25 mg/1 tablet, film coated, extended release, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Paroxetine hydrochloride hemihydrate.

Bryant Ranch Prepack, NDC labeler code 63629. 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 Hydrochloride?

12 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Paroxetine Hydrochloride NDC 63629-8527

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-8527Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-8527Add 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
63629-8527-1	6362985270163629852701	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-8527-1)Marketed from Oct 31, 2014

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 Hydrochloride
Generic name (nonproprietary): paroxetine hydrochloride
Active ingredients: Paroxetine hydrochloride hemihydrate — 25 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Bryant Ranch PrepackNDC labeler code 63629
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204744
Marketing start: Oct 31, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 63629-8527_d72b03fa-f81e-4eab-95aa-00c6c48ebf37SPL ID d72b03fa-f81e-4eab-95aa-00c6c48ebf37SPL set ID 5e47c4fb-6070-4cb4-acaa-c6e90199b55cRxCUI 1738805UNII 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

N463629852701 followed by a unit qualifier and the quantity

Package 63629-8527-01. 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 Jan 11, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Paroxetine is indicated in adults for the treatment of: Major depressive disorder (MDD) Panic disorder (PD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD) Paroxetine is a 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 63629-8527

What is NDC 63629-8527?: 63629-8527 is the product NDC for Paroxetine Hydrochloride, Paroxetine hydrochloride hemihydrate 25 mg/1 tablet, film coated, extended release, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Paroxetine Hydrochloride.
What is the active ingredient?: Paroxetine hydrochloride hemihydrate.
Who is the labeler?: Bryant Ranch Prepack, NDC labeler code 63629. 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 Hydrochloride?: 12 other product NDCs are listed under this name. See all Paroxetine Hydrochloride 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 Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Paroxetine Hydrochloride	Paroxetine hydrochloride 10 mg/5mL	SuspensionOral	Camber Pharmaceuticals, Inc.	31722-578	31722-0578-25
paroxetine hydrochloride	Paroxetine hydrochloride 10 mg/1	Tablet, Film coatedOral	Oxford Pharmaceuticals, LLC	69584-671	69584-0671-0369584-0671-0969584-0671-10+2 more
paroxetine hydrochloride	Paroxetine hydrochloride 20 mg/1	Tablet, Film coatedOral	Oxford Pharmaceuticals, LLC	69584-672	69584-0672-0369584-0672-0969584-0672-10+2 more
paroxetine hydrochloride	Paroxetine hydrochloride 30 mg/1	Tablet, Film coatedOral	Oxford Pharmaceuticals, LLC	69584-673	69584-0673-0369584-0673-0969584-0673-10+2 more
paroxetine hydrochloride	Paroxetine hydrochloride 40 mg/1	Tablet, Film coatedOral	Oxford Pharmaceuticals, LLC	69584-674	69584-0674-0369584-0674-0969584-0674-10+2 more
paroxetine hydrochloride	Paroxetine hydrochloride hemihydrate 30 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-9650	71335-9650-0171335-9650-0271335-9650-03+1 more
Paroxetine Hydrochloride	Paroxetine hydrochloride 12.5 mg/1	Tablet, Film coated, Extended releaseOral	Apotex Corp	60505-1316	60505-1316-03
Paroxetine Hydrochloride	Paroxetine hydrochloride hemihydrate 25 mg/1	Tablet, Film coated, Extended releaseOral	Apotex Corp	60505-1317	60505-1317-03
Paroxetine Hydrochloride	Paroxetine hydrochloride hemihydrate 37.5 mg/1	Tablet, Film coated, Extended releaseOral	Apotex Corp	60505-1318	60505-1318-03
Paroxetine Hydrochloride	Paroxetine hydrochloride 12.5 mg/1	Tablet, Film coated, Extended releaseOral	Lannett Company, Inc.	62175-470	62175-0470-3262175-0470-41

All 13 Paroxetine Hydrochloride NDCs

Other NDCs under ANDA 204744

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

FDA NDC Directory listings under ANDA 204744
Product	Strength	Form · route	Labeler	Product NDC
Paroxetine	Paroxetine hydrochloride 12.5 mg/1	Tablet, Film coated, Extended releaseOral	Chartwell RX, LLC	62135-425
Paroxetine	Paroxetine hydrochloride 25 mg/1	Tablet, Film coated, Extended releaseOral	Chartwell RX, LLC	62135-426
Paroxetine	Paroxetine hydrochloride 37.5 mg/1	Tablet, Film coated, Extended releaseOral	Chartwell RX, LLC	62135-427
Paroxetine Hydrochloride	Paroxetine hydrochloride 12.5 mg/1	Tablet, Film coated, Extended releaseOral	Lannett Company, Inc.	62175-470
Paroxetine Hydrochloride	Paroxetine hydrochloride 25 mg/1	Tablet, Film coated, Extended releaseOral	Lannett Company, Inc.	62175-471
Paroxetine Hydrochloride	Paroxetine hydrochloride 37.5 mg/1	Tablet, Film coated, Extended releaseOral	Lannett Company, Inc.	62175-472