Sertraline
- Product NDC
- 70518-1617
- 11-digit product format
- 705181617
- Labeler code
- 70518
- Product ID
- 70518-1617_494f96d1-de22-da69-e063-6294a90aaa4f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA077670
- Marketing category
- ANDA
- Marketing start
- 2018-10-30
- 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
- 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 | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | UTI8907Y6X |
| Rxcui | 312941 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-1617-0 | Sertraline | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 15 |
| 70518-1617-1 | Sertraline | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-1617 | SERTRALINE TABLET, FILM COATED [REMEDYREPACK INC.] | 12 | Current NDC, Legacy NDC, 2 package rows | 20250226_c614be38-cb45-44a1-b78e-0cdfc0691618.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-1617-0 | 70518161700 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1617-0) | 2018-10-30 | 0000-00-00 | No | No | Current |
| 70518-1617-1 | 70518161701 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1617-1) | 2019-11-27 | 0000-00-00 | No | No | Current |