ATORVASTATIN CALCIUM
- Product NDC
- 63629-8469
- 11-digit product format
- 636298469
- Labeler code
- 63629
- Product ID
- 63629-8469_d6e7f67f-0443-4748-9a44-dc0dadf15253
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ATORVASTATIN CALCIUM
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA205519
- Marketing category
- ANDA
- Marketing start
- 2016-05-19
- 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
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 |
|---|
| 63629-8469-1 | 63629846901 | 90 TABLET, FILM COATED in 1 BOTTLE (63629-8469-1) | 2016-05-19 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| ATORVASTATIN CALCIUM | Bryant Ranch Prepack | 2025-11-11 | HUMAN PRESCRIPTION DRUG LABEL | 104 |
| ATORVASTATIN CALCIUM | Bryant Ranch Prepack | 2024-09-05 | HUMAN PRESCRIPTION DRUG LABEL | 103 |