Paroxetine
- Product NDC
- 70954-319
- 11-digit product format
- 709540319
- Labeler code
- 70954
- Product ID
- 70954-319_367bb2bf-beef-4f9a-b045-0c23e9021701
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paroxetine
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA215003
- Marketing category
- ANDA
- Marketing start
- 2021-09-03
- Substance
- PAROXETINE HYDROCHLORIDE HEMIHYDRATE
- Active strength
- 10 mg/5mL
- 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/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X2ELS050D8 |
| Rxcui | 312242 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70954-319-10 | Paroxetine | 250 mL in 1 BOTTLE | SUSPENSION | 250 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70954-319 | PAROXETINE SUSPENSION [ANI PHARMACEUTICALS, INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20250429_134e76f0-45cf-47eb-b6e1-cdb3bb522a0a.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 |
|---|
| 70954-319-10 | 70954031910 | 250 mL in 1 BOTTLE (70954-319-10) | 250 ml | 2021-09-03 | 0000-00-00 | No | No | Current |