Sertraline
- Product NDC
- 23155-758
- 11-digit product format
- 231550758
- Labeler code
- 23155
- Product ID
- 23155-758_5079a5d2-af51-4bac-aaad-75653da2aa97
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Application
- ANDA076465
- Marketing category
- ANDA
- Marketing start
- 2023-02-23
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 50 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SERTRALINE HYDROCHLORIDE | 50 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 |
|---|
| 23155-758-03 | Sertraline | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
| 23155-758-05 | Sertraline | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 5 |
| 23155-758-09 | Sertraline | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 5 |
| 23155-758-69 | Sertraline | 5000 in 1 BOTTLE | TABLET, FILM COATED | 5000 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 23155-758 | SERTRALINE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] | 4 | Current NDC, 4 package rows | 20240805_444ca054-e450-4c10-a31b-71ad43946cb8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 23155-758-03 | 23155075803 | 30 TABLET, FILM COATED in 1 BOTTLE (23155-758-03) | 2023-02-23 | No | No | Current |
| 23155-758-05 | 23155075805 | 500 TABLET, FILM COATED in 1 BOTTLE (23155-758-05) | 2023-02-23 | No | No | Current |
| 23155-758-09 | 23155075809 | 90 TABLET, FILM COATED in 1 BOTTLE (23155-758-09) | 2023-02-23 | No | No | Current |
| 23155-758-69 | 23155075869 | 5000 TABLET, FILM COATED in 1 BOTTLE (23155-758-69) | 2023-02-23 | No | No | Current |