Paroxetine
- Product NDC
- 71335-0321
- 11-digit product format
- 713350321
- Labeler code
- 71335
- Product ID
- 71335-0321_12cfc765-bf13-4a46-8985-36e31c75fab9
- 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
- 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 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 |
|---|
| 71335-0321-1 | Paroxetine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 17 |
| 71335-0321-2 | Paroxetine | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 17 |
| 71335-0321-3 | Paroxetine | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 17 |
| 71335-0321-4 | Paroxetine | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-0321 | PAROXETINE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 17 | Current NDC, Legacy NDC, 4 package rows | 20250331_0a0f8897-2099-4038-9b96-ed9c4f084018.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 |
|---|
| 71335-0321-1 | 71335032101 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-0321-1) | 2018-02-12 | 0000-00-00 | No | No | Current |
| 71335-0321-2 | 71335032102 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-0321-2) | 2021-12-27 | 0000-00-00 | No | No | Current |
| 71335-0321-3 | 71335032103 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-0321-3) | 2018-05-17 | 0000-00-00 | No | No | Current |
| 71335-0321-4 | 71335032104 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-0321-4) | 2021-12-27 | 0000-00-00 | No | No | Current |