Paroxetine
- Product NDC
- 0574-0279
- 11-digit product format
- 005740279
- Labeler code
- 0574
- Product ID
- 0574-0279_2da9c1a5-7b6c-4990-b6a5-1b06e1dd85cd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paroxetine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Padagis US LLC
- Application
- NDA204516
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2017-10-03
- Substance
- PAROXETINE MESYLATE
- Active strength
- 7.5 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 MESYLATE | 7.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | M711N184JE |
| Rxcui | 1430122 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0574-0279-30 | Paroxetine | 30 in 1 BOTTLE | CAPSULE | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0574-0279 | PAROXETINE CAPSULE [PADAGIS US LLC] | 5 | Current NDC, Legacy NDC, 1 package rows | 20230922_1383d713-79b9-45bd-bd06-65707f28bc99.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 |
|---|
| 0574-0279-30 | 00574027930 | 30 CAPSULE in 1 BOTTLE (0574-0279-30) | 30 capsule | 2017-10-03 | 0000-00-00 | No | No | Current |