Simvastatin is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Biocon Pharma Inc,. The primary component is Simvastatin.
| Product ID | 70377-004_4ea81ae0-c11c-fb4b-7d9a-99bcc5e17dfe |
| NDC | 70377-004 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Simvastatin |
| Generic Name | Simvastatin |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2015-12-17 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA078034 |
| Labeler Name | Biocon Pharma Inc, |
| Substance Name | SIMVASTATIN |
| Active Ingredient Strength | 40 mg/1 |
| Pharm Classes | HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2015-12-17 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA078034 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2015-12-17 |
| Marketing Category | ANDA |
| Application Number | ANDA078034 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2015-12-17 |
| Marketing Category | ANDA |
| Application Number | ANDA078034 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2015-12-17 |
| Marketing Category | ANDA |
| Application Number | ANDA078034 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2015-12-17 |
| Ingredient | Strength |
|---|---|
| SIMVASTATIN | 40 mg/1 |
| SPL SET ID: | 7b325108-6940-50a7-96b4-822a5206e568 |
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