Sertraline
- Product NDC
- 0143-9655
- 11-digit product format
- 001439655
- Labeler code
- 0143
- Product ID
- 0143-9655_f35de481-61af-428e-abb4-a267238b3959
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sertraline hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA077864
- Marketing category
- ANDA
- Marketing start
- 2012-11-06
- Marketing end
- 0000-00-00
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SERTRALINE HYDROCHLORIDE | ACTIVE INGREDIENT | UTI8907Y6X | SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] | 3 | |
| SERTRALINE | ACTIVE MOIETY | QUC7NX6WMB | SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] | 3 | |
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] | 3 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] | 3 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] | 3 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] | 3 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] | 3 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] | 3 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] | 3 | |
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 |
|---|
| 0143-9655-05 | 00143965505 | 500 TABLET, FILM COATED in 1 BOTTLE (0143-9655-05) | 2012-11-06 | 0000-00-00 | No | No | Current |
| 0143-9655-09 | 00143965509 | 90 TABLET, FILM COATED in 1 BOTTLE (0143-9655-09) | 2012-11-06 | 0000-00-00 | No | No | Current |
| 0143-9655-30 | 00143965530 | 30 TABLET, FILM COATED in 1 BOTTLE (0143-9655-30) | 2012-11-06 | 0000-00-00 | No | No | Current |