paroxetine hydrochloride
- Product NDC
- 71335-9650
- 11-digit product format
- 713359650
- Labeler code
- 71335
- Product ID
- 71335-9650_52e74299-f193-408d-9d0d-e48398a1734a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paroxetine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA076968
- Marketing category
- ANDA
- Marketing start
- 2022-11-14
- Substance
- PAROXETINE HYDROCHLORIDE HEMIHYDRATE
- 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 hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X2ELS050D8 |
| Rxcui | 1738503 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-9650-1 | paroxetine hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 102 |
| 71335-9650-2 | paroxetine hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 102 |
| 71335-9650-3 | paroxetine hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 102 |
| 71335-9650-4 | paroxetine hydrochloride | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 102 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-9650 | PAROXETINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 102 | Current NDC, 4 package rows | 20240918_c3c204df-6b7d-42fb-8794-4f38064ed963.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-9650-1 | 71335965001 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-9650-1) | 2023-03-28 | No | No | Historical |
| 71335-9650-2 | 71335965002 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-9650-2) | 2024-09-06 | No | No | Historical |
| 71335-9650-3 | 71335965003 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-9650-3) | 2024-09-06 | No | No | Historical |
| 71335-9650-4 | 71335965004 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-9650-4) | 2024-09-06 | No | No | Historical |