PAROXETINE
- Product NDC
- 62135-542
- 11-digit product format
- 621350542
- Labeler code
- 62135
- Product ID
- 62135-542_4687b126-663e-b64a-e063-6294a90affa1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PAROXETINE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Chartwell RX, LLC.
- Application
- ANDA211248
- Marketing category
- ANDA
- Marketing start
- 2021-11-02
- Substance
- PAROXETINE HYDROCHLORIDE HEMIHYDRATE
- Active strength
- 20 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 HEMIHYDRATE | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X2ELS050D8 |
| Rxcui | 1738483, 1738495, 1738503, 1738511 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-542-90 | PAROXETINE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-542 | PAROXETINE TABLET, FILM COATED [CHARTWELL RX, LLC.] | 2 | Current NDC, 1 package rows | 20241013_69699d40-4a64-4337-8664-e4e093437fbf.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 62135-542-90 | 62135054290 | 90 TABLET, FILM COATED in 1 BOTTLE (62135-542-90) | 2023-04-11 | No | No | Current |