Paroxetine
- Product NDC
- 71335-0544
- 11-digit product format
- 713350544
- Labeler code
- 71335
- Product ID
- 71335-0544_2586816e-d449-4c27-a592-44ad6a2802da
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paroxetine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA077584
- Marketing category
- ANDA
- Marketing start
- 2007-04-13
- 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#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-0544 | PAROXETINE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 103 | Current NDC, Legacy NDC, 7 package rows | 20250331_7a702760-9b72-4595-bf47-01aff786c74d.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 |
|---|
| 71335-0544-1 | 71335054401 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-0544-1) | 2022-02-09 | 0000-00-00 | No | No | Current |
| 71335-0544-2 | 71335054402 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-0544-2) | 2022-02-09 | 0000-00-00 | No | No | Current |
| 71335-0544-3 | 71335054403 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-0544-3) | 2022-02-09 | 0000-00-00 | No | No | Current |
| 71335-0544-4 | 71335054404 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-0544-4) | 2022-02-09 | 0000-00-00 | No | No | Current |
| 71335-0544-5 | 71335054405 | 15 TABLET, FILM COATED in 1 BOTTLE (71335-0544-5) | 2022-02-09 | 0000-00-00 | No | No | Current |
| 71335-0544-6 | 71335054406 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-0544-6) | 2022-02-09 | 0000-00-00 | No | No | Current |
| 71335-0544-7 | 71335054407 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-0544-7) | 2022-02-09 | 0000-00-00 | No | No | Current |