Simvastatin
- Product NDC
- 0093-7152
- 11-digit product format
- 000937152
- Labeler code
- 0093
- Product ID
- 0093-7152_33687dff-291c-43fe-8567-6a35927682eb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA076052
- Marketing category
- ANDA
- Marketing start
- 2006-06-27
- Marketing end
- 2019-10-31
- Substance
- SIMVASTATIN
- Active strength
- 5 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 |
|---|
| SIMVASTATIN | ACTIVE INGREDIENT | AGG2FN16EV | SIMVASTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] | 2 | |
| SIMVASTATIN | ACTIVE MOIETY | AGG2FN16EV | SIMVASTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] | 2 | |
| ASCORBIC ACID | INACTIVE INGREDIENT | PQ6CK8PD0R | SIMVASTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] | 2 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | SIMVASTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SIMVASTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] | 2 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | SIMVASTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | SIMVASTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | SIMVASTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] | 2 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | SIMVASTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] | 2 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | SIMVASTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | SIMVASTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SIMVASTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] | 2 | |
| POLYETHYLENE GLYCOL 3350 | INACTIVE INGREDIENT | G2M7P15E5P | SIMVASTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] | 2 | |
| POLYETHYLENE GLYCOL 4000 | INACTIVE INGREDIENT | 4R4HFI6D95 | SIMVASTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | SIMVASTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SIMVASTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] | 2 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | SIMVASTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] | 2 | |
DailyMed RxNorm Mappings#