Simvastatin
- Product NDC
- 84677-014
- 11-digit product format
- 846770014
- Labeler code
- 84677
- Product ID
- 84677-014_4df35a33-0224-6b3b-e063-6294a90ab67c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Golden State Medical Supply, Inc.
- Application
- ANDA078034
- Marketing category
- ANDA
- Marketing start
- 2006-12-20
- Substance
- SIMVASTATIN
- Active strength
- 5 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Simvastatin
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SIMVASTATIN | 5 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 |
|---|
| 84677-014-10 | Simvastatin | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 2 |
| 84677-014-90 | Simvastatin | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 84677-014-10 | 84677001410 | 1000 TABLET, FILM COATED in 1 BOTTLE (84677-014-10) | 2026-03-10 | No | No | Historical |
| 84677-014-90 | 84677001490 | 90 TABLET, FILM COATED in 1 BOTTLE (84677-014-90) | 2026-03-10 | No | No | Historical |