Simvastatin
- Product NDC
- 70518-4102
- 11-digit product format
- 705184102
- Labeler code
- 70518
- Product ID
- 70518-4102_3fa484c8-160e-af04-e063-6294a90a90ba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA078034
- Marketing category
- ANDA
- Marketing start
- 2024-06-14
- 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
- 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | AGG2FN16EV |
| Rxcui | 312962 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4102-0 | Simvastatin | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 3 |
| 70518-4102-1 | Simvastatin | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4102 | SIMVASTATIN TABLET, FILM COATED [REMEDYREPACK INC.] | 2 | Current NDC, 2 package rows | 20240716_593f0007-9690-4de5-b1e9-59299e587643.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4102-0 | 70518410200 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4102-0) | 2024-06-14 | No | No | Historical |
| 70518-4102-1 | 70518410201 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4102-1) | 2024-07-15 | No | No | Historical |