ATORVASTATIN CALCIUM
- Product NDC
- 71610-633
- 11-digit product format
- 716100633
- Labeler code
- 71610
- Product ID
- 71610-633_24733c5a-94ea-400b-8e16-62cf696802b1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ATORVASTATIN CALCIUM
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA090548
- Marketing category
- ANDA
- Marketing start
- 2021-08-01
- Substance
- ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| YRZ789OWMI | ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE | 1040350-07-9 | ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-633-15 | 71610063315 | 15 TABLET, FILM COATED in 1 BOTTLE (71610-633-15) | 2022-02-07 | No | No | Historical |
| 71610-633-30 | 71610063330 | 30 TABLET, FILM COATED in 1 BOTTLE (71610-633-30) | 2022-02-07 | No | No | Historical |
| 71610-633-45 | 71610063345 | 45 TABLET, FILM COATED in 1 BOTTLE (71610-633-45) | 2022-02-07 | No | No | Historical |
| 71610-633-60 | 71610063360 | 90 TABLET, FILM COATED in 1 BOTTLE (71610-633-60) | 2022-02-07 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| ATORVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | 2022-03-02 | HUMAN PRESCRIPTION DRUG LABEL | 1 |