Paroxetine
- Product NDC
- 62135-427
- 11-digit product format
- 621350427
- Labeler code
- 62135
- Product ID
- 62135-427_efb6b453-333a-211d-e053-2995a90ae2d9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paroxetine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA204744
- Marketing category
- ANDA
- Marketing start
- 2014-10-31
- Substance
- PAROXETINE HYDROCHLORIDE
- Active strength
- 37.5 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 HYDROCHLORIDE | 37.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X2ELS050D8 |
| Rxcui | 1738803, 1738805, 1738807 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-427-30 | Paroxetine | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-427 | PAROXETINE TABLET, FILM COATED, EXTENDED RELEASE [CHARTWELL RX, LLC] | 1 | Current NDC, Legacy NDC, 1 package rows | 20221217_52c3c5c4-6434-4f95-b5f0-9ecfdc0a7e0a.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 |
|---|
| 62135-427-30 | 62135042730 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62135-427-30) | 2022-12-05 | 0000-00-00 | No | No | Current |