SIMVASTATIN
- Product NDC
- 71335-9717
- 11-digit product format
- 713359717
- Labeler code
- 71335
- Product ID
- 71335-9717_0c5ccce8-c8a8-4594-941a-b845294778bf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SIMVASTATIN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA078103
- Marketing category
- ANDA
- Marketing start
- 2016-01-05
- Substance
- SIMVASTATIN
- Active strength
- 80 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 | 80 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | AGG2FN16EV |
| Rxcui | 200345 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-9717-1 | SIMVASTATIN | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 102 |
| 71335-9717-2 | SIMVASTATIN | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 102 |
| 71335-9717-3 | SIMVASTATIN | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 102 |
| 71335-9717-4 | SIMVASTATIN | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 102 |
| 71335-9717-5 | SIMVASTATIN | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 102 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-9717 | SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK] | 101 | Current NDC, 5 package rows | 20240410_aaca7284-d2d8-42e3-b153-ddc3d2ce907c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-9717-1 | 71335971701 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-9717-1) | 2023-04-04 | No | No | Historical |
| 71335-9717-2 | 71335971702 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-9717-2) | 2024-04-05 | No | No | Historical |
| 71335-9717-3 | 71335971703 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-9717-3) | 2023-08-21 | No | No | Historical |
| 71335-9717-4 | 71335971704 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-9717-4) | 2024-04-05 | No | No | Historical |
| 71335-9717-5 | 71335971705 | 10 TABLET, FILM COATED in 1 BOTTLE (71335-9717-5) | 2024-04-05 | No | No | Historical |