Paroxetine
- Product NDC
- 72189-492
- 11-digit product format
- 721890492
- Labeler code
- 72189
- Product ID
- 72189-492_2c4e39ee-1b27-61c5-e063-6394a90aeef5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paroxetine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA077584
- Marketing category
- ANDA
- Marketing start
- 2023-06-21
- Substance
- PAROXETINE HYDROCHLORIDE HEMIHYDRATE
- Active strength
- 10 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 HEMIHYDRATE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X2ELS050D8 |
| Rxcui | 1738483 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72189-492-30 | Paroxetine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-492 | PAROXETINE TABLET, FILM COATED [DIRECT_RX] | 2 | Current NDC, 1 package rows | 20250123_fea936a5-fdeb-e4fb-e053-6294a90a8995.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72189-492-30 | 72189049230 | 30 TABLET, FILM COATED in 1 BOTTLE (72189-492-30) | 2023-06-21 | No | No | Current |