SIMVASTATIN
- Product NDC
- 50090-6236
- 11-digit product format
- 500906236
- Labeler code
- 50090
- Product ID
- 50090-6236_49db7aa2-71f3-49b5-99cc-8e009f94124f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SIMVASTATIN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA078103
- Marketing category
- ANDA
- Marketing start
- 2007-06-12
- 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 |
|---|
| 50090-6236-0 | SIMVASTATIN | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 5 |
| 50090-6236-1 | SIMVASTATIN | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-6236 | SIMVASTATIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 3 | Current NDC, Legacy NDC, 2 package rows | 20231101_e4d8ebf3-7f9f-4725-a104-1d1bf6e6f768.zip |
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 |
|---|
| 50090-6236-0 | 50090623600 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6236-0) | 2022-11-21 | 0000-00-00 | No | No | Current |
| 50090-6236-1 | 50090623601 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-6236-1) | 2022-11-21 | 0000-00-00 | No | No | Current |