Simvastatin
- Product NDC
- 50090-7781
- 11-digit product format
- 500907781
- Labeler code
- 50090
- Product ID
- 50090-7781_319221ea-ac36-44c1-a98b-92e1aa5779d8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA077691
- Marketing category
- ANDA
- Marketing start
- 2006-12-20
- Substance
- SIMVASTATIN
- Active strength
- 20 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 | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | AGG2FN16EV |
| Rxcui | 312961 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-7781-0 | Simvastatin | 45 in 1 BOTTLE | TABLET, FILM COATED | 45 | | 4 |
| 50090-7781-1 | Simvastatin | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 4 |
| 50090-7781-2 | Simvastatin | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-7781-0 | 50090778100 | 45 TABLET, FILM COATED in 1 BOTTLE (50090-7781-0) | 2025-11-20 | No | No | Historical |
| 50090-7781-1 | 50090778101 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7781-1) | 2025-11-20 | No | No | Historical |
| 50090-7781-2 | 50090778102 | 1000 TABLET, FILM COATED in 1 BOTTLE (50090-7781-2) | 2025-11-20 | No | No | Historical |