PAROXETINE
- Product NDC
- 0904-5676
- 11-digit product format
- 009045676
- Labeler code
- 0904
- Product ID
- 0904-5676_9a171d3f-aa1b-4120-82ee-af67f33f167f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paroxetine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA075356
- Marketing category
- ANDA
- Marketing start
- 2003-09-08
- Substance
- PAROXETINE HYDROCHLORIDE ANHYDROUS
- Active strength
- 10 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3I3T11UD2S |
| Rxcui | 1738483, 1738495, 1738503, 1738511 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-5676-61 | PAROXETINE | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 19 |
| 0904-5676-61 | PAROXETINE | 100 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 100 | | 19 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-5676 | PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 17 | Current NDC, Legacy NDC, 2 package rows | 20250213_84b1b1f0-d375-4fda-99af-9487f8ef50c7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0904-5676-61 | 00904567661 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-5676-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 100 blister pack | 2003-09-08 | 0000-00-00 | No | No | Current |