Sertraline Hydrochloride
- Product NDC
- 0143-9580
- 11-digit product format
- 001439580
- Labeler code
- 0143
- Product ID
- 0143-9580_b301fcfc-fb14-46cc-ad49-56c5572c40ba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sertraline hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- West-ward Pharmaceutical Corp
- Application
- ANDA077864
- Marketing category
- ANDA
- Marketing start
- 2009-08-10
- 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
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|
| 0143-9580-05 | Sertraline Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 2 |
| 0143-9580-09 | Sertraline Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
| 0143-9580-30 | Sertraline Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SERTRALINE HYDROCHLORIDE | ACTIVE INGREDIENT | UTI8907Y6X | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | |
| SERTRALINE | ACTIVE MOIETY | QUC7NX6WMB | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | |
| SERTRALINE HYDROCHLORIDE | ACTIVE INGREDIENT | UTI8907Y6X | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 2 | |
| SERTRALINE | ACTIVE MOIETY | QUC7NX6WMB | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 2 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 2 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 2 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 2 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 2 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9580 | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 2 | Legacy NDC, 3 package rows | 20111011_0aee46a9-7c7e-4363-a05d-bf2595930f03.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 0143-9580-05 | 00143958005 | 500 in 1 BOTTLE | Historical |
| 0143-9580-09 | 00143958009 | 90 in 1 BOTTLE | Historical |
| 0143-9580-30 | 00143958030 | 30 in 1 BOTTLE | Historical |