Sertraline
- Product NDC
- 33261-346
- 11-digit product format
- 332610346
- Labeler code
- 33261
- Product ID
- 33261-346_c6cd640f-0dd1-4c1c-bd96-6d1aa77a0c63
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA077670
- Marketing category
- ANDA
- Marketing start
- 2007-02-06
- Marketing end
- 0000-00-00
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 33261-346-30 | Sertraline | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 1 |
| 33261-346-60 | Sertraline | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 1 |
| 33261-346-90 | Sertraline | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SERTRALINE HYDROCHLORIDE | ACTIVE INGREDIENT | UTI8907Y6X | SERTRALINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| SERTRALINE | ACTIVE MOIETY | QUC7NX6WMB | SERTRALINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | SERTRALINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SERTRALINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | SERTRALINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | SERTRALINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | SERTRALINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SERTRALINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | SERTRALINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | SERTRALINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | SERTRALINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SERTRALINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33261-346 | SERTRALINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | Legacy NDC, 3 package rows | 20140213_9b121d06-8de7-4c63-8000-19edc2861b9b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 33261-346-30 | 33261034630 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 33261-346-60 | 33261034660 | 60 in 1 BOTTLE, PLASTIC | Historical |
| 33261-346-90 | 33261034690 | 90 in 1 BOTTLE, PLASTIC | Historical |