Atorvastatin Calcium
- Product NDC
- 43598-831
- 11-digit product format
- 435980831
- Labeler code
- 43598
- Product ID
- 43598-831_14581fb9-c75a-8300-dffc-732f7533a1ef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atorvastatin Calcium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Inc
- Application
- ANDA214659
- Marketing category
- ANDA
- Marketing start
- 2022-08-29
- 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 | 259255, 617310, 617311, 617312 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43598-831-05 | Atorvastatin Calcium | 500 in 1 BOTTLE | TABLET | 500 | | 8 |
| 43598-831-78 | Atorvastatin Calcium | 10 in 1 CARTON | TABLET | 10 | | 8 |
| 43598-831-79 | Atorvastatin Calcium | 10 in 1 BLISTER PACK | TABLET | 10 | | 8 |
| 43598-831-90 | Atorvastatin Calcium | 90 in 1 BOTTLE | TABLET | 90 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-831 | ATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES INC] | 8 | Current NDC, Legacy NDC, 4 package rows | 20240612_652f77a0-2145-896d-c760-e99e87507161.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43598-831-05 | 43598083105 | 500 TABLET in 1 BOTTLE (43598-831-05) | 500 tablet | 2022-08-29 | 0000-00-00 | No | No | Current |
| 43598-831-78 | 43598083178 | 10 BLISTER PACK in 1 CARTON (43598-831-78) / 10 TABLET in 1 BLISTER PACK (43598-831-79) | 10 blister pack | 2022-08-29 | 0000-00-00 | No | No | Current |
| 43598-831-79 | 43598083179 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 43598-831-90 | 43598083190 | 90 TABLET in 1 BOTTLE (43598-831-90) | 90 tablet | 2022-08-29 | 0000-00-00 | No | No | Current |