Prescription drug · ANDA
Paroxetine NDC 69367-337
Paroxetine hydrochloride 37.5 mg/1 · Tablet, Film coated, Extended release · Oral · Westminster Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69367-337-30 | 6936703373069367033730 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69367-337-30)Marketed from Jul 26, 2021 |
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 — 37.5 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Westminster Pharmaceuticals, LLCNDC labeler code 69367
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213485
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 69367-337_0a272d00-5b37-47b2-870a-0028ca799109SPL ID 0a272d00-5b37-47b2-870a-0028ca799109SPL set ID f39a2a7a-7a7e-4dd8-9704-54d9598504fbRxCUI 1738803, 1738805, 1738807UNII X2ELS050D8UPC 0369367337304
- 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
N469367033730followed by a unit qualifier and the quantityPackage 69367-0337-30. 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 . 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 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.
About NDC 69367-337
- What is NDC 69367-337?
- 69367-337 is the product NDC for Paroxetine, Paroxetine hydrochloride 37.5 mg/1 tablet, film coated, extended release, listed with the FDA by Westminster Pharmaceuticals, 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.
- Who is the labeler?
- Westminster Pharmaceuticals, LLC, NDC labeler code 69367. 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.
Related NDCs: other Paroxetine products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 |
Other NDCs under ANDA 213485
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Paroxetine | Paroxetine hydrochloride 12.5 mg/1 | Tablet, Film coated, Extended releaseOral | Westminster Pharmaceuticals, LLC | 69367-335 |
| Paroxetine | Paroxetine hydrochloride 25 mg/1 | Tablet, Film coated, Extended releaseOral | Westminster Pharmaceuticals, LLC | 69367-336 |