atorvastatin calcium
- Product NDC
- 70710-1770
- 11-digit product format
- 707101770
- Labeler code
- 70710
- Product ID
- 70710-1770_223716b7-8d87-4704-a08f-799e2cb5c29e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- atorvastatin calcium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA206536
- Marketing category
- ANDA
- Marketing start
- 2024-06-12
- 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 |
|---|---|
| ATORVASTATIN CALCIUM TRIHYDRATE | 80 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 48A5M73Z4Q |
| Rxcui | 259255, 617310, 617311, 617312 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fa898d56-9495-d6f0-309b-68a5d8e3914a | Product name | 4 | 20260305 |
| d25cba4b-d79e-4890-8837-1382f7d09489 | Product name | 1 | 20231002 |
| 91774e91-b249-45e3-8ff8-4b5db2927a69 | Product name | 1 | 20230718 |
| 03fb3cda-d60a-4873-94e9-6fa77cfb1a1c | Product name | 1 | 20220302 |
| 34152997-af0b-acf4-dcaf-37211afe8ca4 | Product name | 9 | 20210312 |
| 46fdf265-6d5a-1bfb-93db-d82a4ea8aa81 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70710-1770-0 | atorvastatin calcium | 1000 in 1 BOTTLE | TABLET | 1000 | 3 | |
| 70710-1770-5 | atorvastatin calcium | 500 in 1 BOTTLE | TABLET | 500 | 3 | |
| 70710-1770-9 | atorvastatin calcium | 90 in 1 BOTTLE | TABLET | 90 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70710-1770 | ATORVASTATIN CALCIUM TABLET [ZYDUS PHARMACEUTICALS USA INC.] | 2 | Current NDC, 3 package rows | 20240618_55ad4a90-d177-4cce-b7ec-cb75067f6c14.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 617312 | atorvastatin calcium 10 MG Oral Tablet | PSN | 55ad4a90-d177-4cce-b7ec-cb75067f6c14 | 3 |
| 617310 | atorvastatin calcium 20 MG Oral Tablet | PSN | 55ad4a90-d177-4cce-b7ec-cb75067f6c14 | 3 |
| 617311 | atorvastatin calcium 40 MG Oral Tablet | PSN | 55ad4a90-d177-4cce-b7ec-cb75067f6c14 | 3 |
| 259255 | atorvastatin calcium 80 MG Oral Tablet | PSN | 55ad4a90-d177-4cce-b7ec-cb75067f6c14 | 3 |
| 617312 | atorvastatin 10 MG Oral Tablet | SCD | 55ad4a90-d177-4cce-b7ec-cb75067f6c14 | 3 |
| 617310 | atorvastatin 20 MG Oral Tablet | SCD | 55ad4a90-d177-4cce-b7ec-cb75067f6c14 | 3 |
| 617311 | atorvastatin 40 MG Oral Tablet | SCD | 55ad4a90-d177-4cce-b7ec-cb75067f6c14 | 3 |
| 259255 | atorvastatin 80 MG Oral Tablet | SCD | 55ad4a90-d177-4cce-b7ec-cb75067f6c14 | 3 |
| 617312 | atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet | SY | 55ad4a90-d177-4cce-b7ec-cb75067f6c14 | 3 |
| 617310 | atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet | SY | 55ad4a90-d177-4cce-b7ec-cb75067f6c14 | 3 |
| 617311 | atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet | SY | 55ad4a90-d177-4cce-b7ec-cb75067f6c14 | 3 |
| 259255 | atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet | SY | 55ad4a90-d177-4cce-b7ec-cb75067f6c14 | 3 |
| 259255 | atorvastatin calcium 80 MG Oral Tablet | PSN | 9271942d-0151-4434-80de-bbccd8868c9c | 1 |
| 259255 | atorvastatin calcium 80 MG Oral Tablet | PSN | b8a7c3b3-f87e-4112-9998-578b2613da47 | 1 |
| 259255 | atorvastatin 80 MG Oral Tablet | SCD | 9271942d-0151-4434-80de-bbccd8868c9c | 1 |
| 259255 | atorvastatin 80 MG Oral Tablet | SCD | b8a7c3b3-f87e-4112-9998-578b2613da47 | 1 |
| 259255 | atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet | SY | 9271942d-0151-4434-80de-bbccd8868c9c | 1 |
| 259255 | atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet | SY | b8a7c3b3-f87e-4112-9998-578b2613da47 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70710-1770-0 | 70710177000 | 1000 TABLET in 1 BOTTLE (70710-1770-0) | 1000 tablet | 2024-06-12 | No | No | Current |
| 70710-1770-5 | 70710177005 | 500 TABLET in 1 BOTTLE (70710-1770-5) | 500 tablet | 2024-06-12 | No | No | Current |
| 70710-1770-9 | 70710177009 | 90 TABLET in 1 BOTTLE (70710-1770-9) | 90 tablet | 2024-06-12 | No | No | Current |