Atorvastatin calcium
- Product NDC
- 33342-316
- 11-digit product format
- 333420316
- Labeler code
- 33342
- Product ID
- 33342-316_7bd0f0ec-f7a3-4403-9a1a-11f18213631f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atorvastatin calcium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA208480
- Marketing category
- ANDA
- Marketing start
- 2024-06-03
- 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
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 |
|---|---|---|---|---|---|---|
| 33342-316-10 | Atorvastatin calcium | 90 in 1 BOTTLE | TABLET | 90 | 1 | |
| 33342-316-12 | Atorvastatin calcium | 10 in 1 CARTON | TABLET | 10 | 1 | |
| 33342-316-12 | Atorvastatin calcium | 10 in 1 BLISTER PACK | TABLET | 10 | 1 | |
| 33342-316-15 | Atorvastatin calcium | 500 in 1 BOTTLE | TABLET | 500 | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 617312 | atorvastatin calcium 10 MG Oral Tablet | PSN | 7bd0f0ec-f7a3-4403-9a1a-11f18213631f | 1 |
| 617310 | atorvastatin calcium 20 MG Oral Tablet | PSN | 7bd0f0ec-f7a3-4403-9a1a-11f18213631f | 1 |
| 617311 | atorvastatin calcium 40 MG Oral Tablet | PSN | 7bd0f0ec-f7a3-4403-9a1a-11f18213631f | 1 |
| 259255 | atorvastatin calcium 80 MG Oral Tablet | PSN | 7bd0f0ec-f7a3-4403-9a1a-11f18213631f | 1 |
| 617312 | atorvastatin 10 MG Oral Tablet | SCD | 7bd0f0ec-f7a3-4403-9a1a-11f18213631f | 1 |
| 617310 | atorvastatin 20 MG Oral Tablet | SCD | 7bd0f0ec-f7a3-4403-9a1a-11f18213631f | 1 |
| 617311 | atorvastatin 40 MG Oral Tablet | SCD | 7bd0f0ec-f7a3-4403-9a1a-11f18213631f | 1 |
| 259255 | atorvastatin 80 MG Oral Tablet | SCD | 7bd0f0ec-f7a3-4403-9a1a-11f18213631f | 1 |
| 617312 | atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet | SY | 7bd0f0ec-f7a3-4403-9a1a-11f18213631f | 1 |
| 617310 | atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet | SY | 7bd0f0ec-f7a3-4403-9a1a-11f18213631f | 1 |
| 617311 | atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet | SY | 7bd0f0ec-f7a3-4403-9a1a-11f18213631f | 1 |
| 259255 | atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet | SY | 7bd0f0ec-f7a3-4403-9a1a-11f18213631f | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 33342-316-10 | 33342031610 | 90 TABLET in 1 BOTTLE (33342-316-10) | 90 tablet | 2024-06-03 | No | No | Historical |
| 33342-316-12 | 33342031612 | 10 BLISTER PACK in 1 CARTON (33342-316-12) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2024-06-03 | No | No | Historical |
| 33342-316-15 | 33342031615 | 500 TABLET in 1 BOTTLE (33342-316-15) | 500 tablet | 2024-06-03 | No | No | Historical |