ATORVASTATIN CALCIUM
- Product NDC
- 16729-047
- 11-digit product format
- 167290047
- Labeler code
- 16729
- Product ID
- 16729-047_40828d2e-69eb-5d38-e063-6394a90abd70
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ATORVASTATIN CALCIUM
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Accord Healthcare Inc.
- Application
- ANDA207687
- Marketing category
- ANDA
- Marketing start
- 2018-08-06
- 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
- 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 | 80 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 |
|---|
| 16729-047-01 | ATORVASTATIN CALCIUM | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 13 |
| 16729-047-10 | ATORVASTATIN CALCIUM | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 13 |
| 16729-047-15 | ATORVASTATIN CALCIUM | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 13 |
| 16729-047-16 | ATORVASTATIN CALCIUM | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 13 |
| 16729-047-17 | ATORVASTATIN CALCIUM | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-047 | ATORVASTATIN CALCIUM TABLET, FILM COATED [ACCORD HEALTHCARE INC.] | 12 | Current NDC, Legacy NDC, 5 package rows | 20241004_4e06b20d-cc5d-46eb-991b-5972248de3af.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 |
|---|
| 16729-047-01 | 16729004701 | 100 in 1 BOTTLE | | | | | Historical |
| 16729-047-10 | 16729004710 | 30 in 1 BOTTLE | | | | | Historical |
| 16729-047-15 | 16729004715 | 90 TABLET, FILM COATED in 1 BOTTLE (16729-047-15) | 2021-07-13 | 0000-00-00 | No | No | Current |
| 16729-047-16 | 16729004716 | 500 TABLET, FILM COATED in 1 BOTTLE (16729-047-16) | 2018-08-06 | 0000-00-00 | No | No | Current |
| 16729-047-17 | 16729004717 | 1000 in 1 BOTTLE | | | | | Historical |