Simvastatin is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company, Inc.. The primary component is Simvastatin.
| Product ID | 76519-1004_25eeeb36-7337-49e8-a1ef-731e8afcca43 |
| NDC | 76519-1004 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Simvastatin |
| Generic Name | Simvastatin |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2007-08-16 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA078425 |
| Labeler Name | H.J. Harkins Company, Inc. |
| Substance Name | SIMVASTATIN |
| Active Ingredient Strength | 5 mg/1 |
| Pharm Classes | HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
| Marketing Start Date | 2007-08-16 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA078425 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2007-08-16 |
| Inactivation Date | 2019-11-13 |
| Ingredient | Strength |
|---|---|
| SIMVASTATIN | 5 mg/1 |
| SPL SET ID: | b1f2911f-f8e1-41c0-9979-cb8d683d2f2f |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0093-7152 | Simvastatin | Simvastatin |
| 0093-7153 | Simvastatin | Simvastatin |
| 0093-7154 | Simvastatin | Simvastatin |
| 0093-7155 | Simvastatin | Simvastatin |
| 0093-7156 | Simvastatin | Simvastatin |
| 0179-0128 | Simvastatin | Simvastatin |
| 0179-0240 | simvastatin | simvastatin |
| 0179-0241 | simvastatin | simvastatin |
| 0179-0242 | simvastatin | simvastatin |
| 0179-0243 | simvastatin | simvastatin |
| 0179-1897 | Simvastatin | Simvastatin |
| 0179-1898 | Simvastatin | Simvastatin |
| 0179-1899 | Simvastatin | Simvastatin |
| 0615-6579 | Simvastatin | Simvastatin |
| 0615-6580 | Simvastatin | Simvastatin |
| 0615-6581 | Simvastatin | Simvastatin |
| 0615-6587 | Simvastatin | Simvastatin |
| 0615-6588 | Simvastatin | Simvastatin |
| 0615-7704 | Simvastatin | Simvastatin |
| 0615-7705 | Simvastatin | Simvastatin |
| 0615-7706 | Simvastatin | Simvastatin |
| 68071-1646 | simvastatin | simvastatin |
| 68071-1965 | simvastatin | simvastatin |
| 68071-1721 | simvastatin | simvastatin |
| 68071-1711 | simvastatin | simvastatin |
| 68071-2092 | Simvastatin | Simvastatin |
| 68071-1990 | simvastatin | simvastatin |
| 68071-1699 | simvastatin | simvastatin |
| 68071-1868 | simvastatin | simvastatin |
| 68071-1946 | simvastatin | simvastatin |
| 68071-3115 | Simvastatin | Simvastatin |
| 68071-3391 | simvastatin | simvastatin |
| 68071-3157 | Simvastatin | Simvastatin |
| 68071-3289 | simvastatin | simvastatin |
| 68071-4331 | SIMVASTATIN | SIMVASTATIN |
| 68071-4504 | simvastatin | simvastatin |
| 68084-512 | Simvastatin | Simvastatin |
| 68151-0177 | Simvastatin | Simvastatin |
| 68084-511 | Simvastatin | Simvastatin |
| 68180-481 | SIMVASTATIN | SIMVASTATIN |
| 68180-482 | SIMVASTATIN | SIMVASTATIN |
| 68180-465 | SIMVASTATIN | SIMVASTATIN |
| 68180-478 | SIMVASTATIN | SIMVASTATIN |
| 68180-480 | SIMVASTATIN | SIMVASTATIN |
| 68180-464 | SIMVASTATIN | SIMVASTATIN |
| 68180-479 | SIMVASTATIN | SIMVASTATIN |
| 68382-069 | Simvastatin | Simvastatin |
| 68382-067 | Simvastatin | Simvastatin |
| 68382-065 | Simvastatin | Simvastatin |
| 68382-068 | Simvastatin | Simvastatin |