ATORVASTATIN CALCIUM
- Product NDC
- 82804-161
- 11-digit product format
- 828040161
- Labeler code
- 82804
- Product ID
- 82804-161_2b9a52e2-5666-4de0-b4da-afbed05ea2be
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ATORVASTATIN CALCIUM
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA214344
- Marketing category
- ANDA
- Marketing start
- 2023-09-12
- 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 |
|---|
| 82804-161-30 | 82804016130 | 30 TABLET, FILM COATED in 1 BOTTLE (82804-161-30) | 2024-11-13 | No | No | Historical |
| 82804-161-90 | 82804016190 | 90 TABLET, FILM COATED in 1 BOTTLE (82804-161-90) | 2024-10-21 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| ATORVASTATIN CALCIUM | Proficient Rx LP | 2024-11-01 | HUMAN PRESCRIPTION DRUG LABEL | 2 |