Sertraline
- Product NDC
- 70518-0938
- 11-digit product format
- 705180938
- Labeler code
- 70518
- Product ID
- 70518-0938_4d3a81d1-1c26-b2ff-e063-6394a90ac7e3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA077670
- Marketing category
- ANDA
- Marketing start
- 2018-01-05
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sertraline
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SERTRALINE HYDROCHLORIDE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | UTI8907Y6X |
| Rxcui | 312940 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-0938-0 | Sertraline | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 8 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-0938-0 | 70518093800 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0938-0) | 2018-01-05 | No | No | Current |