Paroxetine
- Product NDC
- 50090-5987
- 11-digit product format
- 500905987
- Labeler code
- 50090
- Product ID
- 50090-5987_3e8cfd15-4821-46d2-ae90-827bb859f71a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paroxetine hydrochloride hemihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA203854
- Marketing category
- ANDA
- Marketing start
- 2014-11-01
- Substance
- PAROXETINE HYDROCHLORIDE ANHYDROUS
- Active strength
- 30 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Paroxetine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PAROXETINE HYDROCHLORIDE ANHYDROUS | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3I3T11UD2S |
| Rxcui | 1738503 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-5987-0 | Paroxetine | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-5987 | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240719_525884d7-e2ee-4d57-a6c9-bd129e9fb9d0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50090-5987-0 | 50090598700 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-5987-0) | 2022-06-02 | 0000-00-00 | No | No | Current |