ATORVASTATIN CALCIUM
- Product NDC
- 31722-427
- 11-digit product format
- 317220427
- Labeler code
- 31722
- Product ID
- 31722-427_3afbe0e5-4ded-60ee-e063-6294a90a13a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ATORVASTATIN CALCIUM
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA214344
- Marketing category
- ANDA
- Marketing start
- 2023-09-12
- 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 |
|---|---|---|---|---|---|---|
| 31722-427-05 | ATORVASTATIN CALCIUM | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | 5 | |
| 31722-427-10 | ATORVASTATIN CALCIUM | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 5 | |
| 31722-427-90 | ATORVASTATIN CALCIUM | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 31722-427-05 | EA - Each | 31722-427 | 5bd2ad9c-8dfb-4c29-a041-70773a6b97f6 | 1 | 2024-03-12 |
| 31722-427-10 | EA - Each | 31722-427 | f7179d52-9a67-4540-9403-fcefbe99133a | 1 | 2024-08-12 |
| 31722-427-90 | EA - Each | 31722-427 | de3e24b7-cd6b-4b2c-8e85-c1d9015fdfa2 | 1 | 2024-03-12 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 617312 | atorvastatin calcium 10 MG Oral Tablet | PSN | 25c8f92f-9cb6-482b-82e1-16ad7c94e7b3 | 5 |
| 617310 | atorvastatin calcium 20 MG Oral Tablet | PSN | 25c8f92f-9cb6-482b-82e1-16ad7c94e7b3 | 5 |
| 617311 | atorvastatin calcium 40 MG Oral Tablet | PSN | 25c8f92f-9cb6-482b-82e1-16ad7c94e7b3 | 5 |
| 259255 | atorvastatin calcium 80 MG Oral Tablet | PSN | 49e0e9e7-447d-4d9d-847e-46d68a77db2d | 5 |
| 259255 | atorvastatin calcium 80 MG Oral Tablet | PSN | 25c8f92f-9cb6-482b-82e1-16ad7c94e7b3 | 5 |
| 617312 | atorvastatin 10 MG Oral Tablet | SCD | 25c8f92f-9cb6-482b-82e1-16ad7c94e7b3 | 5 |
| 617310 | atorvastatin 20 MG Oral Tablet | SCD | 25c8f92f-9cb6-482b-82e1-16ad7c94e7b3 | 5 |
| 617311 | atorvastatin 40 MG Oral Tablet | SCD | 25c8f92f-9cb6-482b-82e1-16ad7c94e7b3 | 5 |
| 259255 | atorvastatin 80 MG Oral Tablet | SCD | 49e0e9e7-447d-4d9d-847e-46d68a77db2d | 5 |
| 259255 | atorvastatin 80 MG Oral Tablet | SCD | 25c8f92f-9cb6-482b-82e1-16ad7c94e7b3 | 5 |
| 617312 | atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet | SY | 25c8f92f-9cb6-482b-82e1-16ad7c94e7b3 | 5 |
| 617310 | atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet | SY | 25c8f92f-9cb6-482b-82e1-16ad7c94e7b3 | 5 |
| 617311 | atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet | SY | 25c8f92f-9cb6-482b-82e1-16ad7c94e7b3 | 5 |
| 259255 | atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet | SY | 25c8f92f-9cb6-482b-82e1-16ad7c94e7b3 | 5 |
| 259255 | atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet | SY | 49e0e9e7-447d-4d9d-847e-46d68a77db2d | 5 |
| 259255 | atorvastatin calcium 80 MG Oral Tablet | PSN | a4185ea4-8fc1-4af5-99b1-6e49f0c46463 | 3 |
| 259255 | atorvastatin calcium 80 MG Oral Tablet | PSN | 330d488b-794d-416b-8ec7-073946e3fdf5 | 3 |
| 259255 | atorvastatin 80 MG Oral Tablet | SCD | a4185ea4-8fc1-4af5-99b1-6e49f0c46463 | 3 |
| 259255 | atorvastatin 80 MG Oral Tablet | SCD | 330d488b-794d-416b-8ec7-073946e3fdf5 | 3 |
| 259255 | atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet | SY | 330d488b-794d-416b-8ec7-073946e3fdf5 | 3 |
| 259255 | atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet | SY | a4185ea4-8fc1-4af5-99b1-6e49f0c46463 | 3 |
| 259255 | atorvastatin calcium 80 MG Oral Tablet | PSN | 276efbe2-bf86-9f38-e063-6294a90a8589 | 1 |
| 259255 | atorvastatin 80 MG Oral Tablet | SCD | 276efbe2-bf86-9f38-e063-6294a90a8589 | 1 |
| 259255 | atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet | SY | 276efbe2-bf86-9f38-e063-6294a90a8589 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 31722-427-05 | 31722042705 | 500 TABLET, FILM COATED in 1 BOTTLE (31722-427-05) | 2023-09-12 | No | No | Current |
| 31722-427-10 | 31722042710 | 1000 TABLET, FILM COATED in 1 BOTTLE (31722-427-10) | 2024-04-25 | No | No | Current |
| 31722-427-90 | 31722042790 | 90 TABLET, FILM COATED in 1 BOTTLE (31722-427-90) | 2023-09-12 | No | No | Current |