Atorvastatin Calcium
- Product NDC
- 71335-2388
- 11-digit product format
- 713352388
- Labeler code
- 71335
- Product ID
- 71335-2388_351d59d0-e7fd-a0c6-e063-6394a90ab9ba
- 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
- 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
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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 48A5M73Z4Q |
| Rxcui | 617312 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2388-1 | 71335238801 | 30 TABLET in 1 BOTTLE (71335-2388-1) | 30 tablet | 2024-05-29 | No | No | Historical |
| 71335-2388-2 | 71335238802 | 90 TABLET in 1 BOTTLE (71335-2388-2) | 90 tablet | 2024-05-29 | No | No | Historical |
| 71335-2388-3 | 71335238803 | 60 TABLET in 1 BOTTLE (71335-2388-3) | 60 tablet | 2024-05-29 | No | No | Historical |
| 71335-2388-4 | 71335238804 | 120 TABLET in 1 BOTTLE (71335-2388-4) | 120 tablet | 2024-05-29 | No | No | Historical |
| 71335-2388-5 | 71335238805 | 100 TABLET in 1 BOTTLE (71335-2388-5) | 100 tablet | 2024-05-29 | No | No | Historical |
| 71335-2388-6 | 71335238806 | 180 TABLET in 1 BOTTLE (71335-2388-6) | 180 tablet | 2024-05-29 | No | No | Historical |