Atorvastatin calcium
- Product NDC
- 71335-2799
- 11-digit product format
- 713352799
- Labeler code
- 71335
- Product ID
- 71335-2799_55560bb6-85b8-4e62-bd68-33ced6dac155
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atorvastatin calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA211933
- Marketing category
- ANDA
- Marketing start
- 2019-02-08
- Substance
- ATORVASTATIN CALCIUM TRIHYDRATE
- Active strength
- 20 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
- 71335-2799_55560bb6-85b8-4e62-bd68-33ced6dac155
- 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
- 2019-02-08
- 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 | 20 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 48A5M73Z4Q |
| Rxcui | 617310 |
| Spl Set Id | f1f3e4e0-5407-4831-9885-3a37e72356c0 |
| Manufacturer Name | Bryant Ranch Prepack |
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 |
|---|
| 71335-2799-1 | 71335279901 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2799-1) | 2025-10-13 | No | No | Current |
| 71335-2799-2 | 71335279902 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2799-2) | 2025-10-13 | No | No | Current |
| 71335-2799-3 | 71335279903 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2799-3) | 2025-10-13 | No | No | Current |
| 71335-2799-4 | 71335279904 | 9 TABLET, FILM COATED in 1 BOTTLE (71335-2799-4) | 2025-10-13 | No | No | Current |
| 71335-2799-5 | 71335279905 | 28 TABLET, FILM COATED in 1 BOTTLE (71335-2799-5) | 2025-10-13 | No | No | Current |
| 71335-2799-6 | 71335279906 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-2799-6) | 2025-10-13 | No | No | Current |
| 71335-2799-7 | 71335279907 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-2799-7) | 2025-10-13 | No | No | Current |
| 71335-2799-8 | 71335279908 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-2799-8) | 2025-10-13 | No | No | Current |
| 71335-2799-9 | 71335279909 | 7 TABLET, FILM COATED in 1 BOTTLE (71335-2799-9) | 2025-10-13 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Atorvastatin calcium | Bryant Ranch Prepack | 2025-10-13 | HUMAN PRESCRIPTION DRUG LABEL | 1 |