Simvastatin
- Product NDC
- 70377-004
- 11-digit product format
- 703770004
- Labeler code
- 70377
- Product ID
- 70377-004_4d832ba0-8b5c-de5a-246a-a5f30e884bb4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Biocon Pharma Inc,
- Application
- ANDA078034
- Marketing category
- ANDA
- Marketing start
- 2015-12-17
- Substance
- SIMVASTATIN
- Active strength
- 40 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Simvastatin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SIMVASTATIN | 40 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 |
|---|
| 70377-004-12 | Simvastatin | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 12 |
| 70377-004-13 | Simvastatin | 45 in 1 BOTTLE | TABLET, FILM COATED | 45 | | 12 |
| 70377-004-14 | Simvastatin | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 12 |
| 70377-004-15 | Simvastatin | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70377-004 | SIMVASTATIN TABLET, FILM COATED [BIOCON PHARMA INC,] | 12 | Current NDC, Legacy NDC, 4 package rows | 20250326_7b325108-6940-50a7-96b4-822a5206e568.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 |
|---|
| 70377-004-12 | 70377000412 | 30 TABLET, FILM COATED in 1 BOTTLE (70377-004-12) | 2015-12-17 | 0000-00-00 | No | No | Current |
| 70377-004-13 | 70377000413 | 45 TABLET, FILM COATED in 1 BOTTLE (70377-004-13) | 2015-12-17 | 0000-00-00 | No | No | Current |
| 70377-004-14 | 70377000414 | 90 TABLET, FILM COATED in 1 BOTTLE (70377-004-14) | 2015-12-17 | 0000-00-00 | No | No | Current |
| 70377-004-15 | 70377000415 | 1000 TABLET, FILM COATED in 1 BOTTLE (70377-004-15) | 2015-12-17 | 0000-00-00 | No | No | Current |