Sertraline Hydrochloride
- Product NDC
- 0904-6924
- 11-digit product format
- 009046924
- Labeler code
- 0904
- Product ID
- 0904-6924_e586e0c5-ace8-4575-a549-f4c85a351653
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA077670
- Marketing category
- ANDA
- Marketing start
- 2007-02-06
- Marketing end
- 2027-09-30
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 25 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
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SERTRALINE HYDROCHLORIDE | 25 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 |
|---|
| 0904-6924-61 | Sertraline Hydrochloride | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 8 |
| 0904-6924-61 | Sertraline Hydrochloride | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6924 | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 6 | Current NDC, Legacy NDC, 2 package rows | 20250509_4cf8d5c8-842b-4e7c-9a99-3f41ef8abbdb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0904-6924-61 | 00904692461 | 100 BLISTER PACK in 1 CARTON (0904-6924-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 100 blister pack | 2007-02-06 | 0000-00-00 | No | No | Current |