Atorvastatin calcium
- Product NDC
- 33342-318
- 11-digit product format
- 333420318
- Labeler code
- 33342
- Product ID
- 33342-318_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
- 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 table| Ingredient | Strength |
|---|
| ATORVASTATIN CALCIUM TRIHYDRATE | 80 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 |
|---|
| 33342-318-10 | Atorvastatin calcium | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
| 33342-318-12 | Atorvastatin calcium | 10 in 1 CARTON | TABLET | 10 | | 1 |
| 33342-318-12 | Atorvastatin calcium | 10 in 1 BLISTER PACK | TABLET | 10 | | 1 |
| 33342-318-15 | Atorvastatin calcium | 500 in 1 BOTTLE | TABLET | 500 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 33342-318-10 | 33342031810 | 90 TABLET in 1 BOTTLE (33342-318-10) | 90 tablet | 2024-06-03 | No | No | Historical |
| 33342-318-12 | 33342031812 | 10 BLISTER PACK in 1 CARTON (33342-318-12) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2024-06-03 | No | No | Historical |
| 33342-318-15 | 33342031815 | 500 TABLET in 1 BOTTLE (33342-318-15) | 500 tablet | 2024-06-03 | No | No | Historical |