Paroxetine
- Product NDC
- 69367-335
- 11-digit product format
- 693670335
- Labeler code
- 69367
- Product ID
- 69367-335_0a272d00-5b37-47b2-870a-0028ca799109
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paroxetine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Westminster Pharmaceuticals, LLC
- Application
- ANDA213485
- Marketing category
- ANDA
- Marketing start
- 2021-07-26
- Substance
- PAROXETINE HYDROCHLORIDE
- Active strength
- 12.5 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 | 12.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X2ELS050D8 |
| Rxcui | 1738803, 1738805, 1738807 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69367-335-30 | Paroxetine | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69367-335 | PAROXETINE TABLET, FILM COATED, EXTENDED RELEASE [WESTMINSTER PHARMACEUTICALS, LLC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20231006_f39a2a7a-7a7e-4dd8-9704-54d9598504fb.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 |
|---|
| 69367-335-30 | 69367033530 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69367-335-30) | 2021-07-26 | 0000-00-00 | No | No | Current |