ATORVASTATIN CALCIUM
- Product NDC
- 77771-451
- 11-digit product format
- 777710451
- Labeler code
- 77771
- Product ID
- 77771-451_323762eb-66a3-4b6b-8e40-3374cc230a93
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ATORVASTATIN CALCIUM
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Radha Pharmaceuticals, Inc.
- Application
- ANDA205519
- Marketing category
- ANDA
- Marketing start
- 2023-08-10
- Substance
- ATORVASTATIN CALCIUM TRIHYDRATE
- Active strength
- 10 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 48A5M73Z4Q |
| Rxcui | 259255, 617310, 617311, 617312 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 77771-451-10 | ATORVASTATIN CALCIUM | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 3 |
| 77771-451-90 | ATORVASTATIN CALCIUM | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 77771-451 | ATORVASTATIN CALCIUM TABLET, FILM COATED [RADHA PHARMACEUTICALS, INC.] | 2 | Current NDC, 2 package rows | 20241027_10e766cc-c3fd-4584-a0d7-652c516e828c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 77771-451-10 | 77771045110 | 1000 TABLET, FILM COATED in 1 BOTTLE (77771-451-10) | 2023-08-10 | No | No | Current |
| 77771-451-90 | 77771045190 | 90 TABLET, FILM COATED in 1 BOTTLE (77771-451-90) | 2023-08-10 | No | No | Current |