Sertraline Hydrochloride
- Product NDC
- 70954-900
- 11-digit product format
- 709540900
- Labeler code
- 70954
- Product ID
- 70954-900_dfc9fee6-c032-4994-9f14-5beaf39bb5d5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA219714
- Marketing category
- ANDA
- Marketing start
- 2026-01-20
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sertraline Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SERTRALINE HYDROCHLORIDE | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | UTI8907Y6X |
| Rxcui | 251201, 410584 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70954-900-10 | Sertraline Hydrochloride | 30 in 1 BOTTLE | CAPSULE | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70954-900-10 | 70954090010 | 30 CAPSULE in 1 BOTTLE (70954-900-10) | 30 capsule | 2026-01-20 | No | No | Current |