Atorvastatin Calcium
- Product NDC
- 71335-2582
- 11-digit product format
- 713352582
- Labeler code
- 71335
- Product ID
- 71335-2582_cb1eb8aa-f460-4c50-b341-97bc1aa6ee76
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- atorvastatin calcium, film coated
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA209912
- Marketing category
- ANDA
- Marketing start
- 2023-10-20
- Substance
- ATORVASTATIN CALCIUM TRIHYDRATE
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Atorvastatin Calcium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ATORVASTATIN CALCIUM TRIHYDRATE | 80 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 48A5M73Z4Q |
| Rxcui | 259255 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2582-1 | 71335258201 | 30 TABLET in 1 BOTTLE (71335-2582-1) | 30 tablet | 2025-04-03 | No | No | Historical |
| 71335-2582-2 | 71335258202 | 60 TABLET in 1 BOTTLE (71335-2582-2) | 60 tablet | 2025-04-03 | No | No | Historical |
| 71335-2582-3 | 71335258203 | 90 TABLET in 1 BOTTLE (71335-2582-3) | 90 tablet | 2025-04-03 | No | No | Historical |
| 71335-2582-4 | 71335258204 | 180 TABLET in 1 BOTTLE (71335-2582-4) | 180 tablet | 2025-04-03 | No | No | Historical |