Simvastatin
- Product NDC
- 67046-671
- 11-digit product format
- 670460671
- Labeler code
- 67046
- Product ID
- 67046-671_13c80d46-429e-4007-8f89-eed2ed96eccf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Contract Pharmacy Services-PA
- Application
- ANDA077752
- Marketing category
- ANDA
- Marketing start
- 2010-06-17
- Marketing end
- 0000-00-00
- Substance
- SIMVASTATIN
- Active strength
- 20 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase 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 Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Simvastatin | ACTIVE INGREDIENT | AGG2FN16EV | SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA] | 1 | |
| Simvastatin | ACTIVE MOIETY | AGG2FN16EV | SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA] | 1 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA] | 1 | |
| ascorbic acid | INACTIVE INGREDIENT | PQ6CK8PD0R | SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA] | 1 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA] | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA] | 1 | |
| hypromellose | INACTIVE INGREDIENT | 3NXW29V3WO | SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA] | 1 | |
| isopropyl alcohol | INACTIVE INGREDIENT | ND2M416302 | SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA] | 1 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA] | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA] | 1 | |