SERTRALINE
- Product NDC
- 76282-212
- 11-digit product format
- 762820212
- Labeler code
- 76282
- Product ID
- 76282-212_5c34aa64-3f25-4d6e-8fbb-98aa3688f72d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Exelan Pharmaceuticals, Inc.
- Application
- ANDA077397
- Marketing category
- ANDA
- Marketing start
- 2012-08-20
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SERTRALINE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SERTRALINE HYDROCHLORIDE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | UTI8907Y6X |
| Rxcui | 312938, 312940, 312941 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76282-212-01 | SERTRALINE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 8 |
| 76282-212-05 | SERTRALINE | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 8 |
| 76282-212-18 | SERTRALINE | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 8 |
| 76282-212-30 | SERTRALINE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 8 |
| 76282-212-60 | SERTRALINE | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 8 |
| 76282-212-90 | SERTRALINE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SERTRALINE HYDROCHLORIDE | ACTIVE INGREDIENT | UTI8907Y6X | SERTRALINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] | 1 | |
| SERTRALINE HYDROCHLORIDE | ACTIVE INGREDIENT | UTI8907Y6X | SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| SERTRALINE | ACTIVE MOIETY | QUC7NX6WMB | SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| SERTRALINE | ACTIVE MOIETY | QUC7NX6WMB | SERTRALINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] | 1 | |
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | SERTRALINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SERTRALINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | SERTRALINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | SERTRALINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | SERTRALINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | SERTRALINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | SERTRALINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | SERTRALINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| INDIGOTINDISULFONATE SODIUM | INACTIVE INGREDIENT | D3741U8K7L | SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| INDIGOTINDISULFONATE SODIUM | INACTIVE INGREDIENT | D3741U8K7L | SERTRALINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SERTRALINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | SERTRALINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | SERTRALINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | SERTRALINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SERTRALINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76282-212 | SERTRALINE (SERTRALINE) TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] | 8 | Current NDC, Legacy NDC, 6 package rows | 20231118_2dac437f-b5ef-42dd-aa0b-1f4b9b45ef43.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 |
|---|
| 76282-212-01 | 76282021201 | 100 TABLET, FILM COATED in 1 BOTTLE (76282-212-01) | 2012-08-20 | 0000-00-00 | No | No | Current |
| 76282-212-05 | 76282021205 | 500 TABLET, FILM COATED in 1 BOTTLE (76282-212-05) | 2012-08-20 | 0000-00-00 | No | No | Current |
| 76282-212-18 | 76282021218 | 180 TABLET, FILM COATED in 1 BOTTLE (76282-212-18) | 2012-08-20 | 0000-00-00 | No | No | Current |
| 76282-212-30 | 76282021230 | 30 TABLET, FILM COATED in 1 BOTTLE (76282-212-30) | 2012-08-20 | 0000-00-00 | No | No | Current |
| 76282-212-60 | 76282021260 | 60 TABLET, FILM COATED in 1 BOTTLE (76282-212-60) | 2012-08-20 | 0000-00-00 | No | No | Current |
| 76282-212-90 | 76282021290 | 90 TABLET, FILM COATED in 1 BOTTLE (76282-212-90) | 2012-08-20 | 0000-00-00 | No | No | Current |