SERTRALINE HYDROCHLORIDE
- Product NDC
- 50228-469
- 11-digit product format
- 502280469
- Labeler code
- 50228
- Product ID
- 50228-469_09a95635-597e-d608-e063-6294a90a203f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SERTRALINE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- ScieGen Pharmaceuticals Inc
- Application
- ANDA076442
- Marketing category
- ANDA
- Marketing start
- 2023-05-08
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Cytochrome P450 2D6 Inhibitors [MoA], 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
- SERTRALINE HYDROCHLORIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SERTRALINE HYDROCHLORIDE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | UTI8907Y6X |
| Rxcui | 312938, 312940, 312941 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50228-469-05 | SERTRALINE HYDROCHLORIDE | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | | 2 |
| 50228-469-30 | SERTRALINE HYDROCHLORIDE | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 2 |
| 50228-469-90 | SERTRALINE HYDROCHLORIDE | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50228-469 | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS INC] | 2 | Current NDC, 3 package rows | 20231109_10b9cae4-b452-4abb-866a-9f9d2568f212.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50228-469-05 | 50228046905 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50228-469-05) | 2023-05-08 | No | No | Historical |
| 50228-469-30 | 50228046930 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50228-469-30) | 2023-05-08 | No | No | Historical |
| 50228-469-90 | 50228046990 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50228-469-90) | 2023-05-08 | No | No | Historical |