ATORVASTATIN CALCIUM
- Product NDC
- 50228-452
- 11-digit product format
- 502280452
- Labeler code
- 50228
- Product ID
- 50228-452_19c6b2b4-fbba-44dd-8668-bec63b285506
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ATORVASTATIN CALCIUM
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- ScieGen Pharmaceuticals, Inc.
- Application
- ANDA205519
- Marketing category
- ANDA
- Marketing start
- 2016-05-19
- 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
- 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 | 20 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 |
|---|
| 50228-452-05 | ATORVASTATIN CALCIUM | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 19 |
| 50228-452-90 | ATORVASTATIN CALCIUM | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 19 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50228-452 | ATORVASTATIN CALCIUM TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] | 17 | Current NDC, Legacy NDC, 2 package rows | 20240802_f2d8b5e9-6ff2-4efa-ab01-e13df29f7371.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 |
|---|
| 50228-452-05 | 50228045205 | 500 TABLET, FILM COATED in 1 BOTTLE (50228-452-05) | 2016-05-19 | 0000-00-00 | No | No | Current |
| 50228-452-90 | 50228045290 | 90 TABLET, FILM COATED in 1 BOTTLE (50228-452-90) | 2016-05-19 | 0000-00-00 | No | No | Current |