ATORVASTATIN CALCIUM
- Product NDC
- 82009-178
- 11-digit product format
- 820090178
- Labeler code
- 82009
- Product ID
- 82009-178_3cc5dd82-b074-c0e2-e063-6394a90aa46e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ATORVASTATIN CALCIUM
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Quallent Pharmaceuticals Health LLC
- Application
- ANDA214344
- Marketing category
- ANDA
- Marketing start
- 2025-08-01
- Substance
- ATORVASTATIN CALCIUM TRIHYDRATE
- Active strength
- 40 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 | 40 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 |
|---|---|---|---|---|---|---|
| 82009-178-10 | ATORVASTATIN CALCIUM | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 82009-178-10 | EA - Each | 82009-178 | 419704ce-23bf-4a6d-b7c3-3103fab4f6bc | 1 | 2025-10-14 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 617312 | atorvastatin calcium 10 MG Oral Tablet | PSN | 5b94b6f4-6f64-4551-abcb-8e845fb13813 | 3 |
| 617310 | atorvastatin calcium 20 MG Oral Tablet | PSN | 5b94b6f4-6f64-4551-abcb-8e845fb13813 | 3 |
| 617311 | atorvastatin calcium 40 MG Oral Tablet | PSN | 5b94b6f4-6f64-4551-abcb-8e845fb13813 | 3 |
| 259255 | atorvastatin calcium 80 MG Oral Tablet | PSN | 5b94b6f4-6f64-4551-abcb-8e845fb13813 | 3 |
| 617312 | atorvastatin 10 MG Oral Tablet | SCD | 5b94b6f4-6f64-4551-abcb-8e845fb13813 | 3 |
| 617310 | atorvastatin 20 MG Oral Tablet | SCD | 5b94b6f4-6f64-4551-abcb-8e845fb13813 | 3 |
| 617311 | atorvastatin 40 MG Oral Tablet | SCD | 5b94b6f4-6f64-4551-abcb-8e845fb13813 | 3 |
| 259255 | atorvastatin 80 MG Oral Tablet | SCD | 5b94b6f4-6f64-4551-abcb-8e845fb13813 | 3 |
| 617312 | atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet | SY | 5b94b6f4-6f64-4551-abcb-8e845fb13813 | 3 |
| 617310 | atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet | SY | 5b94b6f4-6f64-4551-abcb-8e845fb13813 | 3 |
| 617311 | atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet | SY | 5b94b6f4-6f64-4551-abcb-8e845fb13813 | 3 |
| 259255 | atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet | SY | 5b94b6f4-6f64-4551-abcb-8e845fb13813 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 82009-178-10 | 82009017810 | 1000 TABLET, FILM COATED in 1 BOTTLE (82009-178-10) | 2025-08-01 | No | No | Current |