Paroxetine
- Product NDC
- 71610-056
- 11-digit product format
- 716100056
- Labeler code
- 71610
- Product ID
- 71610-056_dc77c275-c420-46bc-863a-cfe7ef2881be
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paroxetine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA078406
- Marketing category
- ANDA
- Marketing start
- 2009-12-03
- Substance
- PAROXETINE HYDROCHLORIDE HEMIHYDRATE
- 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 HEMIHYDRATE | 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 |
|---|
| 71610-056-15 | Paroxetine | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 1 |
| 71610-056-45 | 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 |
|---|
| 71610-056 | PAROXETINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20180514_30fd2fc4-f661-44c9-a9a9-9d0de0892e3c.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 |
|---|
| 71610-056-15 | 71610005615 | 15 TABLET, FILM COATED in 1 BOTTLE (71610-056-15) | 2018-05-02 | 0000-00-00 | No | No | Current |
| 71610-056-45 | 71610005645 | 45 TABLET, FILM COATED in 1 BOTTLE (71610-056-45) | 2018-05-02 | 0000-00-00 | No | No | Current |