ATORVASTATIN CALCIUM
- Product NDC
- 71610-744
- 11-digit product format
- 716100744
- Labeler code
- 71610
- Product ID
- 71610-744_5866cff8-7c35-4050-a75f-5e235b9d39b2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ATORVASTATIN CALCIUM
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA205519
- Marketing category
- ANDA
- Marketing start
- 2023-08-10
- 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 |
|---|
| 71610-744-15 | 71610074415 | 15 TABLET, FILM COATED in 1 BOTTLE (71610-744-15) | 2023-10-24 | No | No | Historical |
| 71610-744-30 | 71610074430 | 30 TABLET, FILM COATED in 1 BOTTLE (71610-744-30) | 2023-10-24 | No | No | Historical |
| 71610-744-45 | 71610074445 | 45 TABLET, FILM COATED in 1 BOTTLE (71610-744-45) | 2023-10-24 | No | No | Historical |
| 71610-744-53 | 71610074453 | 60 TABLET, FILM COATED in 1 BOTTLE (71610-744-53) | 2023-10-24 | No | No | Historical |
| 71610-744-60 | 71610074460 | 90 TABLET, FILM COATED in 1 BOTTLE (71610-744-60) | 2023-10-24 | No | No | Historical |
| 71610-744-70 | 71610074470 | 120 TABLET, FILM COATED in 1 BOTTLE (71610-744-70) | 2023-10-24 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| ATORVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | 2023-10-25 | HUMAN PRESCRIPTION DRUG LABEL | 1 |