Prescription drug · ANDA
Paroxetine (Paroxetine hydrochloride) NDC 0904-5677
Paroxetine hydrochloride anhydrous 20 mg/1 · Tablet, Film coated · Oral · Major Pharmaceuticals
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0904-5677Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00904-5677Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-5677-61 | 0090456776100904567761 | 100 BLISTER PACK in 1 CARTON (0904-5677-61) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Sep 8, 2003 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 hydrochloride
- Active ingredients
- Paroxetine hydrochloride anhydrous — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Major PharmaceuticalsNDC labeler code 0904
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075356
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 0904-5677_1aadea03-718a-4b63-bb15-b23e171ad993SPL ID 1aadea03-718a-4b63-bb15-b23e171ad993
- 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
N400904567761followed by a unit qualifier and the quantityPackage 00904-5677-61. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 0904-5677
- What is NDC 0904-5677?
- 0904-5677 is the product NDC for Paroxetine (paroxetine hydrochloride), Paroxetine hydrochloride anhydrous 20 mg/1 tablet, film coated, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Paroxetine (Paroxetine hydrochloride).
- What is the active ingredient?
- Paroxetine hydrochloride anhydrous.
- Who is the labeler?
- Major Pharmaceuticals, NDC labeler code 0904. 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 075356
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 |
|---|---|---|---|---|
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 20 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2871 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 20 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 67544-317 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 40 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 67544-492 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 20 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-7999 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 40 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-992 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 40 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0993 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 30 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 60429-736 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 10 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 60429-734 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 20 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 60429-735 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 40 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 60429-737 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 30 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1460 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 20 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-0083 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 30 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-0084 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 10 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-0097 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 40 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-0101 |
| Paroxetineparoxetine hydrochloride | Paroxetine hydrochloride anhydrous 10 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-5676 |