PAROXETINE
- Product NDC
- 67544-317
- 11-digit product format
- 675440317
- Labeler code
- 67544
- Product ID
- 67544-317_4569b4c4-1f9a-4dcb-96f7-296bb6ef34e7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paroxetine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA075356
- Marketing category
- ANDA
- Marketing start
- 2003-09-08
- Substance
- PAROXETINE HYDROCHLORIDE ANHYDROUS
- Active strength
- 20 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 ANHYDROUS | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3I3T11UD2S |
| Rxcui | 1738495 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67544-317-15 | PAROXETINE | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 1 |
| 67544-317-45 | PAROXETINE | 45 in 1 BOTTLE | TABLET, FILM COATED | 45 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67544-317 | PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20181114_1801246b-02c3-430f-932a-b18cb0d13d1d.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 |
|---|
| 67544-317-15 | 67544031715 | 15 TABLET, FILM COATED in 1 BOTTLE (67544-317-15) | 2018-04-30 | 0000-00-00 | No | No | Current |
| 67544-317-45 | 67544031745 | 45 TABLET, FILM COATED in 1 BOTTLE (67544-317-45) | 2018-10-12 | 0000-00-00 | No | No | Current |