SIMVASTATIN
- Product NDC
- 70518-1426
- 11-digit product format
- 705181426
- Labeler code
- 70518
- Product ID
- 70518-1426_52439d60-ccbd-070b-e063-6294a90ad60a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SIMVASTATIN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA078103
- Marketing category
- ANDA
- Marketing start
- 2018-09-18
- Substance
- SIMVASTATIN
- Active strength
- 10 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | AGG2FN16EV |
| Rxcui | 314231 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-1426-0 | SIMVASTATIN | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 16 |
| 70518-1426-1 | SIMVASTATIN | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 16 |
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 |
|---|
| 70518-1426-0 | 70518142600 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1426-0) | 2018-09-18 | 0000-00-00 | No | No | Current |
| 70518-1426-1 | 70518142601 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1426-1) | 2025-09-09 | | No | No | Historical |