Sertraline Hydrochloride
- Product NDC
- 72789-013
- 11-digit product format
- 727890013
- Labeler code
- 72789
- Product ID
- 72789-013_2b9a4ac0-8999-2dfc-e063-6394a90a70e1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA077206
- Marketing category
- ANDA
- Marketing start
- 2007-02-06
- 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 |
|---|
| 72789-013-30 | Sertraline Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 36 |
| 72789-013-60 | Sertraline Hydrochloride | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 36 |
| 72789-013-90 | Sertraline Hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 36 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-013 | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 36 | Current NDC, Legacy NDC, 3 package rows | 20250115_ae3be25b-2bde-4142-ad56-920a96ac8f39.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 |
|---|
| 72789-013-30 | 72789001330 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-013-30) | 2019-09-24 | 0000-00-00 | No | No | Current |
| 72789-013-60 | 72789001360 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-013-60) | 2020-11-06 | 0000-00-00 | No | No | Current |
| 72789-013-90 | 72789001390 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-013-90) | 2019-09-24 | 0000-00-00 | No | No | Current |