SIMVASTATIN
- Product NDC
- 60760-580
- 11-digit product format
- 607600580
- Labeler code
- 60760
- Product ID
- 60760-580_48ec78c0-2691-0283-e063-6394a90a2553
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SIMVASTATIN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- ST. MARY'S MEDICAL PARK PHARMACY
- Application
- ANDA078103
- Marketing category
- ANDA
- Marketing start
- 2023-04-13
- 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 |
|---|
| 60760-580-30 | SIMVASTATIN | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60760-580 | SIMVASTATIN TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY] | 1 | Current NDC, 1 package rows | 20230422_f94e5e28-f0b1-700a-e053-6394a90adb7b.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 60760-580-30 | 60760058030 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-580-30) | 2023-04-13 | No | No | Current |