PAROXETINE
- Product NDC
- 63629-9498
- 11-digit product format
- 636299498
- Labeler code
- 63629
- Product ID
- 63629-9498_8053ba32-fceb-458d-898a-00ecf06b685d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PAROXETINE HYDROCHLORIDE HEMIHYDRATE
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA209293
- Marketing category
- ANDA
- Marketing start
- 2018-09-14
- Marketing end
- 2026-07-31
- Substance
- PAROXETINE HYDROCHLORIDE HEMIHYDRATE
- Active strength
- 12.5 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PAROXETINE
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | 12.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X2ELS050D8 |
| Rxcui | 1738803 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-9498-1 | PAROXETINE | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 104 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-9498 | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK] | 103 | Current NDC, Legacy NDC, 1 package rows | 20240724_27729943-8046-4342-af60-bc1da229abac.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 |
|---|
| 63629-9498-1 | 63629949801 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-9498-1) | 2018-09-14 | 2026-07-31 | No | No | Current |