Atorvastatin calcium
- Product NDC
- 68788-4008
- 11-digit product format
- 687884008
- Labeler code
- 68788
- Product ID
- 68788-4008_4ff0d618-cde4-49ae-8bcb-98dafc3ecdba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atorvastatin calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA211933
- Marketing category
- ANDA
- Marketing start
- 2025-08-08
- Substance
- ATORVASTATIN CALCIUM TRIHYDRATE
- Active strength
- 10 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
- 68788-4008_4ff0d618-cde4-49ae-8bcb-98dafc3ecdba
- SPL ID
- 4ff0d618-cde4-49ae-8bcb-98dafc3ecdba
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Atorvastatin calcium
- Generic name
- Atorvastatin calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing start
- 2025-08-08
- Marketing category
- ANDA
- Application number
- ANDA211933
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC]; Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| ATORVASTATIN CALCIUM TRIHYDRATE | 10 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 48A5M73Z4Q |
| Rxcui | 617312 |
| Spl Set Id | 4ff0d618-cde4-49ae-8bcb-98dafc3ecdba |
| Manufacturer Name | Preferred Pharmaceuticals Inc. |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 68788-4008-1 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-4008-1) | 2025-08-08 | No |
| 68788-4008-3 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-4008-3) | 2025-08-08 | No |
| 68788-4008-6 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-4008-6) | 2025-08-08 | No |
| 68788-4008-9 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-4008-9) | 2025-08-08 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 48A5M73Z4Q | ATORVASTATIN CALCIUM TRIHYDRATE | 344423-98-9 | ATORVASTATIN CALCIUM TRIHYDRATE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-4008-1 | 68788400801 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-4008-1) | 2025-08-08 | No | No | Historical |
| 68788-4008-3 | 68788400803 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-4008-3) | 2025-08-08 | No | No | Historical |
| 68788-4008-6 | 68788400806 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-4008-6) | 2025-08-08 | No | No | Historical |
| 68788-4008-9 | 68788400809 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-4008-9) | 2025-08-08 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Atorvastatin calcium | Preferred Pharmaceuticals Inc. | 2025-08-08 | HUMAN PRESCRIPTION DRUG LABEL | 1 |