Paroxetine
- Product NDC
- 46708-768
- 11-digit product format
- 467080768
- Labeler code
- 46708
- Product ID
- 46708-768_e7609c36-21f5-42e2-8d74-ddaf8f94233f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paroxetine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA217280
- Marketing category
- ANDA
- Marketing start
- 2025-09-30
- Substance
- PAROXETINE HYDROCHLORIDE HEMIHYDRATE
- Active strength
- 37.5 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Paroxetine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | 37.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X2ELS050D8 |
| Rxcui | 1738803, 1738805, 1738807 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-768-30 | Paroxetine | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 2 |
| 46708-768-91 | Paroxetine | 1000 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 1000 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 46708-768-30 | 46708076830 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-768-30) | 2025-09-30 | No | No | Current |
| 46708-768-91 | 46708076891 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-768-91) | 2025-09-30 | No | No | Current |