Paroxetine
- Product NDC
- 68071-1740
- 11-digit product format
- 680711740
- Labeler code
- 68071
- Product ID
- 68071-1740_1d5082fe-1cd7-39a8-e063-6294a90ac90f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paroxetine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA077584
- Marketing category
- ANDA
- Marketing start
- 2007-04-13
- Substance
- PAROXETINE HYDROCHLORIDE HEMIHYDRATE
- 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 HEMIHYDRATE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X2ELS050D8 |
| Rxcui | 1738483 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-1740-1 | Paroxetine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-1740 | PAROXETINE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20240716_570a9f0d-04fb-2922-e054-00144ff88e88.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 |
|---|
| 68071-1740-1 | 68071174001 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-1740-1) | 2017-08-18 | 0000-00-00 | No | No | Current |