Paroxetine
- Product NDC
- 62332-767
- 11-digit product format
- 623320767
- Labeler code
- 62332
- Product ID
- 62332-767_3646151d-201e-4bcb-aec9-95b266de2f9e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paroxetine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA217280
- Marketing category
- ANDA
- Marketing start
- 2025-09-30
- Substance
- PAROXETINE HYDROCHLORIDE HEMIHYDRATE
- Active strength
- 25 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 | 25 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 |
|---|
| 62332-767-30 | Paroxetine | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 5 |
| 62332-767-91 | Paroxetine | 1000 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 1000 | | 5 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 62332-767-30 | 62332076730 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62332-767-30) | 2025-09-30 | No | No | Current |
| 62332-767-91 | 62332076791 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62332-767-91) | 2025-09-30 | No | No | Current |