What is NDC 71209-095?

71209-095 is the product NDC for Paroxetine, Paroxetine hydrochloride hemihydrate 25 mg/1 tablet, film coated, extended release, listed with the FDA by Cadila Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Paroxetine hydrochloride hemihydrate.

Cadila Pharmaceuticals Limited, NDC labeler code 71209. 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 71209-095 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71209-095Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71209-0095Add 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
71209-095-01	7120900950171209009501	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71209-095-01)Marketed from Feb 14, 2020
71209-095-10	7120900951071209009510	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71209-095-10)Marketed from Feb 14, 2020

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 — 25 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Cadila Pharmaceuticals LimitedNDC labeler code 71209
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212645
Marketing start: Feb 14, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 71209-095_03756846-6e37-4c43-9a84-58e06801336aSPL ID 03756846-6e37-4c43-9a84-58e06801336aSPL set ID 5e43cdbd-2419-434b-96b9-920f02558d1cRxCUI 1738803, 1738805, 1738807UNII 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

N471209009501 followed by a unit qualifier and the quantity

Package 71209-0095-01. 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 Mar 28, 2024. 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 71209-095

What is NDC 71209-095?: 71209-095 is the product NDC for Paroxetine, Paroxetine hydrochloride hemihydrate 25 mg/1 tablet, film coated, extended release, listed with the FDA by Cadila 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?: Cadila Pharmaceuticals Limited, NDC labeler code 71209. 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 212645

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

FDA NDC Directory listings under ANDA 212645
Product	Strength	Form · route	Labeler	Product NDC
Paroxetine	Paroxetine hydrochloride hemihydrate 12.5 mg/1	Tablet, Film coated, Extended releaseOral	Cadila Pharmaceuticals Limited	71209-094
Paroxetine	Paroxetine hydrochloride hemihydrate 37.5 mg/1	Tablet, Film coated, Extended releaseOral	Cadila Pharmaceuticals Limited	71209-096
Paroxetine	Paroxetine hydrochloride hemihydrate 12.5 mg/1	Tablet, Film coated, Extended releaseOral	Modavar Pharmaceuticals LLC	72241-029
Paroxetine	Paroxetine hydrochloride hemihydrate 25 mg/1	Tablet, Film coated, Extended releaseOral	Modavar Pharmaceuticals LLC	72241-030
Paroxetine	Paroxetine hydrochloride hemihydrate 37.5 mg/1	Tablet, Film coated, Extended releaseOral	Modavar Pharmaceuticals LLC	72241-031