ATORVASTATIN CALCIUM
- Product NDC
- 71610-022
- 11-digit product format
- 716100022
- Labeler code
- 71610
- Product ID
- 71610-022_eb3a5903-a3fa-4071-8e0b-38edfb013464
- 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
- 2012-05-29
- 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
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 | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 48A5M73Z4Q |
| Rxcui | 617310 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-022-45 | ATORVASTATIN CALCIUM | 45 in 1 BOTTLE | TABLET, FILM COATED | 45 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-022 | ATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | Current NDC, Legacy NDC, 1 package rows | 20190530_c0b4f1a2-0082-4150-8f2b-e7440252b675.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 |
|---|
| 71610-022-45 | 71610002245 | 45 TABLET, FILM COATED in 1 BOTTLE (71610-022-45) | 2017-12-20 | 0000-00-00 | No | No | Current |