Simvastatin
- Product NDC
- 72189-427
- 11-digit product format
- 721890427
- Labeler code
- 72189
- Product ID
- 72189-427_2c4d6a3b-c897-d5fd-e063-6294a90ac734
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA078103
- Marketing category
- ANDA
- Marketing start
- 2023-03-01
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72189-427-30 | Simvastatin | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 72189-427-90 | Simvastatin | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-427 | SIMVASTATIN TABLET, FILM COATED [DIRECT_RX] | 3 | Current NDC, 2 package rows | 20250123_f5dd1835-6d40-40da-e053-2a95a90ad121.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72189-427-30 | 72189042730 | 30 TABLET, FILM COATED in 1 BOTTLE (72189-427-30) | 2023-03-01 | No | No | Historical |
| 72189-427-90 | 72189042790 | 90 TABLET, FILM COATED in 1 BOTTLE (72189-427-90) | 2023-03-01 | No | No | Historical |