Atorvastatin Calcium
- Product NDC
- 82804-054
- 11-digit product format
- 828040054
- Labeler code
- 82804
- Product ID
- 82804-054_f3af6315-08b5-4ff9-80ae-2984f0598611
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- atorvastatin calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA216436
- Marketing category
- ANDA
- Marketing start
- 2023-03-01
- 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
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 |
|---|
| 82804-054-30 | 82804005430 | 30 TABLET, FILM COATED in 1 BOTTLE (82804-054-30) | 2023-12-28 | No | No | Historical |
| 82804-054-60 | 82804005460 | 60 TABLET, FILM COATED in 1 BOTTLE (82804-054-60) | 2023-12-28 | No | No | Historical |
| 82804-054-90 | 82804005490 | 90 TABLET, FILM COATED in 1 BOTTLE (82804-054-90) | 2023-12-28 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Atorvastatin Calcium | Proficient Rx LP | 2023-12-01 | HUMAN PRESCRIPTION DRUG LABEL | 1 |