Paroxetine
- Product NDC
- 68788-6870
- 11-digit product format
- 687886870
- Labeler code
- 68788
- Product ID
- 68788-6870_eeb6d4a2-3a77-4a51-a01a-cba3a844adc4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paroxetine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA077584
- Marketing category
- ANDA
- Marketing start
- 2017-01-11
- Substance
- PAROXETINE HYDROCHLORIDE
- Active strength
- 40 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 | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X2ELS050D8 |
| Rxcui | 1738511 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-6870-1 | Paroxetine | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 8 |
| 68788-6870-3 | Paroxetine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 8 |
| 68788-6870-6 | Paroxetine | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 8 |
| 68788-6870-8 | Paroxetine | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 8 |
| 68788-6870-9 | Paroxetine | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-6870 | PAROXETINE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] | 7 | Current NDC, Legacy NDC, 5 package rows | 20240730_7d558598-6905-46da-8f34-668456c68411.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 |
|---|
| 68788-6870-1 | 68788687001 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-6870-1) | 2017-01-11 | 0000-00-00 | No | No | Current |
| 68788-6870-3 | 68788687003 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-6870-3) | 2017-01-11 | 0000-00-00 | No | No | Current |
| 68788-6870-6 | 68788687006 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-6870-6) | 2017-01-11 | 0000-00-00 | No | No | Current |
| 68788-6870-8 | 68788687008 | 120 TABLET, FILM COATED in 1 BOTTLE (68788-6870-8) | 2017-01-11 | 0000-00-00 | No | No | Current |
| 68788-6870-9 | 68788687009 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-6870-9) | 2017-01-11 | 0000-00-00 | No | No | Current |