ATORVASTATIN CALCIUM
- Product NDC
- 71610-163
- 11-digit product format
- 716100163
- Labeler code
- 71610
- Product ID
- 71610-163_505bc442-3fe2-427f-89d9-3057dc391b38
- 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
- 2017-11-16
- Substance
- ATORVASTATIN CALCIUM TRIHYDRATE
- Active strength
- 40 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ATORVASTATIN CALCIUM
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ATORVASTATIN CALCIUM TRIHYDRATE | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 48A5M73Z4Q |
| Rxcui | 617311 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-163-15 | ATORVASTATIN CALCIUM | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 1 |
| 71610-163-30 | ATORVASTATIN CALCIUM | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 71610-163-45 | ATORVASTATIN CALCIUM | 45 in 1 BOTTLE | TABLET, FILM COATED | 45 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-163 | ATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Current NDC, Legacy NDC, 3 package rows | 20181023_ed8e76a5-6b40-47fe-9018-25bfe690a4dd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71610-163-15 | 71610016315 | 15 TABLET, FILM COATED in 1 BOTTLE (71610-163-15) | 2018-10-01 | 0000-00-00 | No | No | Current |
| 71610-163-30 | 71610016330 | 30 TABLET, FILM COATED in 1 BOTTLE (71610-163-30) | 2018-10-01 | 0000-00-00 | No | No | Current |
| 71610-163-45 | 71610016345 | 45 TABLET, FILM COATED in 1 BOTTLE (71610-163-45) | 2018-10-01 | 0000-00-00 | No | No | Current |