SIMVASTATIN
- Product NDC
- 68788-8406
- 11-digit product format
- 687888406
- Labeler code
- 68788
- Product ID
- 68788-8406_1543148a-712a-4cae-881a-105deb09d756
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SIMVASTATIN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA078103
- Marketing category
- ANDA
- Marketing start
- 2023-03-29
- 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
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 68788-8406_1543148a-712a-4cae-881a-105deb09d756
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- SIMVASTATIN
- Generic name
- SIMVASTATIN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing start
- 2023-03-29
- Marketing category
- ANDA
- Application number
- ANDA078103
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC]; Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| SIMVASTATIN | 80 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | AGG2FN16EV |
| Rxcui | 200345 |
| Spl Set Id | 68f6c856-ea98-4872-b4df-a6e9e70444fc |
| Manufacturer Name | Preferred Pharmaceuticals, Inc. |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| AGG2FN16EV | SIMVASTATIN | 79902-63-9 | SIMVASTATIN |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8406-1 | 68788840601 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-8406-1) | 2023-03-29 | No | No | Current |
| 68788-8406-3 | 68788840603 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8406-3) | 2023-03-29 | No | No | Current |
| 68788-8406-6 | 68788840606 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8406-6) | 2023-03-29 | No | No | Current |
| 68788-8406-9 | 68788840609 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8406-9) | 2023-03-29 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| SIMVASTATIN | Preferred Pharmaceuticals, Inc. | 2025-09-23 | HUMAN PRESCRIPTION DRUG LABEL | 3 |