Simvastatin
- Product NDC
- 65862-050
- 11-digit product format
- 658620050
- Labeler code
- 65862
- Product ID
- 65862-050_854ac8f7-cca5-434c-a611-9c1752260d4a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA077691
- Marketing category
- ANDA
- Marketing start
- 2006-12-20
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Simvastatin
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SIMVASTATIN | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | AGG2FN16EV |
| Rxcui | 198211, 200345, 312961, 312962, 314231 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65862-050-00 | Simvastatin | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 29 |
| 65862-050-01 | Simvastatin | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 29 |
| 65862-050-26 | Simvastatin | 2500 in 1 BOTTLE | TABLET, FILM COATED | 2500 | | 29 |
| 65862-050-30 | Simvastatin | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 29 |
| 65862-050-45 | Simvastatin | 45 in 1 BOTTLE | TABLET, FILM COATED | 45 | | 29 |
| 65862-050-90 | Simvastatin | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 29 |
| 65862-050-99 | Simvastatin | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 29 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SIMVASTATIN | ACTIVE INGREDIENT | AGG2FN16EV | SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 15 | |
| SIMVASTATIN | ACTIVE MOIETY | AGG2FN16EV | SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 15 | |
| ASCORBIC ACID | INACTIVE INGREDIENT | PQ6CK8PD0R | SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 15 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 15 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 15 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 15 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 15 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 15 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 15 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 15 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 15 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 15 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 15 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 15 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 15 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 15 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-050 | SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 28 | Current NDC, Legacy NDC, 7 package rows | 20240104_4724dbb4-3613-4e6a-948f-a43d34f97f06.zip |
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 |
|---|
| 65862-050-00 | 65862005000 | 100 TABLET, FILM COATED in 1 BOTTLE (65862-050-00) | 2006-12-20 | 0000-00-00 | No | No | Current |
| 65862-050-01 | 65862005001 | 100 TABLET, FILM COATED in 1 BOTTLE (65862-050-01) | 2006-12-20 | 0000-00-00 | No | No | Current |
| 65862-050-26 | 65862005026 | 2500 TABLET, FILM COATED in 1 BOTTLE (65862-050-26) | 2006-12-20 | 0000-00-00 | No | No | Current |
| 65862-050-30 | 65862005030 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-050-30) | 2006-12-20 | 0000-00-00 | No | No | Current |
| 65862-050-45 | 65862005045 | 45 TABLET, FILM COATED in 1 BOTTLE (65862-050-45) | 2006-12-20 | 0000-00-00 | No | No | Current |
| 65862-050-90 | 65862005090 | 90 TABLET, FILM COATED in 1 BOTTLE (65862-050-90) | 2006-12-20 | 0000-00-00 | No | No | Current |
| 65862-050-99 | 65862005099 | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-050-99) | 2006-12-20 | 0000-00-00 | No | No | Current |