Sertraline hydrochloride
- Product NDC
- 70518-4157
- 11-digit product format
- 705184157
- Labeler code
- 70518
- Product ID
- 70518-4157_40945805-6f2c-74a1-e063-6394a90a04a3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA078403
- Marketing category
- ANDA
- Marketing start
- 2024-08-13
- 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 hydrochloride
- 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 | 312941 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4157-0 | Sertraline hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 5 |
| 70518-4157-1 | Sertraline hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4157 | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.] | 3 | Current NDC, 2 package rows | 20241212_9d49e2cb-a852-403d-b92b-e7d3fa88032c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4157-0 | 70518415700 | 30 in 1 BOTTLE, PLASTIC | | | | Historical |
| 70518-4157-1 | 70518415701 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4157-1) | 2024-09-18 | No | No | Current |