Simvastatin
- Product NDC
- 70518-3648
- 11-digit product format
- 705183648
- Labeler code
- 70518
- Product ID
- 70518-3648_4f6efb24-a569-58e4-e063-6394a90a4bbc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA078034
- Marketing category
- ANDA
- Marketing start
- 2023-02-16
- 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 |
|---|
| 70518-3648-0 | Simvastatin | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 6 |
| 70518-3648-1 | Simvastatin | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3648 | SIMVASTATIN TABLET, FILM COATED [REMEDYREPACK INC.] | 3 | Current NDC, 2 package rows | 20240328_807e5be4-6f87-48b4-8a3b-e4ad1061e706.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-3648-0 | 70518364800 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3648-0) | 2023-02-16 | No | No | Historical |
| 70518-3648-1 | 70518364801 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3648-1) | 2023-02-21 | No | No | Historical |