Atorvastatin Calcium
- Product NDC
- 72189-537
- 11-digit product format
- 721890537
- Labeler code
- 72189
- Product ID
- 72189-537_4c4a77d3-dc1f-704f-e063-6394a90ad5a6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atorvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA211933
- Marketing category
- ANDA
- Marketing start
- 2024-02-26
- Substance
- ATORVASTATIN CALCIUM TRIHYDRATE
- Active strength
- 80 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Atorvastatin Calcium
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ATORVASTATIN CALCIUM TRIHYDRATE | 80 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 48A5M73Z4Q |
| Rxcui | 259255 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72189-537-30 | Atorvastatin Calcium | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 72189-537-90 | Atorvastatin Calcium | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-537 | ATORVASTATIN CALCIUM TABLET, FILM COATED [DIRECT_RX] | 1 | Current NDC, 2 package rows | 20240228_124c111c-9272-eca9-e063-6394a90a0ad5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72189-537-30 | 72189053730 | 30 TABLET, FILM COATED in 1 BOTTLE (72189-537-30) | 2024-02-26 | No | No | Historical |
| 72189-537-90 | 72189053790 | 90 TABLET, FILM COATED in 1 BOTTLE (72189-537-90) | 2024-02-26 | No | No | Historical |