PAROXETINE HYDROCHLORIDE
- Product NDC
- 31722-578
- 11-digit product format
- 317220578
- Labeler code
- 31722
- Product ID
- 31722-578_5092043a-0e8c-05e1-e063-6394a90ad3dc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PAROXETINE HYDROCHLORIDE
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA219954
- Marketing category
- ANDA
- Marketing start
- 2026-03-05
- Substance
- PAROXETINE HYDROCHLORIDE
- Active strength
- 10 mg/5mL
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PAROXETINE HYDROCHLORIDE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PAROXETINE HYDROCHLORIDE | 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 |
|---|
| 31722-578-25 | PAROXETINE HYDROCHLORIDE | 1 in 1 CARTON | SUSPENSION | 1 | | 1 |
| 31722-578-25 | PAROXETINE HYDROCHLORIDE | 250 mL in 1 BOTTLE | SUSPENSION | 250 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 31722-578-25 | 31722057825 | 1 BOTTLE in 1 CARTON (31722-578-25) / 250 mL in 1 BOTTLE | 1 bottle | 2026-03-05 | No | No | Current |