Atorvastatin Calcium
- Product NDC
- 76420-948
- 11-digit product format
- 764200948
- Labeler code
- 76420
- Product ID
- 76420-948_352ed2e2-c7bd-ae21-e063-6394a90ad835
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atorvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA209288
- Marketing category
- ANDA
- Marketing start
- 2018-12-23
- 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 |
|---|
| 76420-948-00 | Atorvastatin Calcium | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 2 |
| 76420-948-05 | Atorvastatin Calcium | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 2 |
| 76420-948-12 | Atorvastatin Calcium | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 2 |
| 76420-948-20 | Atorvastatin Calcium | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 2 |
| 76420-948-30 | Atorvastatin Calcium | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 76420-948-38 | Atorvastatin Calcium | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 2 |
| 76420-948-38 | Atorvastatin Calcium | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 2 |
| 76420-948-60 | Atorvastatin Calcium | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 2 |
| 76420-948-90 | Atorvastatin Calcium | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-948 | ATORVASTATIN CALCIUM TABLET, FILM COATED [ASCLEMED USA, INC.] | 2 | Current NDC, 9 package rows | 20250516_60d51f39-8086-4434-affe-88ab8ca0c7e5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-948-00 | 76420094800 | 1000 TABLET, FILM COATED in 1 BOTTLE (76420-948-00) | | 2025-04-08 | No | No | Historical |
| 76420-948-05 | 76420094805 | 500 TABLET, FILM COATED in 1 BOTTLE (76420-948-05) | | 2025-04-08 | No | No | Historical |
| 76420-948-12 | 76420094812 | 120 TABLET, FILM COATED in 1 BOTTLE (76420-948-12) | | 2025-04-08 | No | No | Historical |
| 76420-948-20 | 76420094820 | 20 TABLET, FILM COATED in 1 BOTTLE (76420-948-20) | | 2025-04-08 | No | No | Historical |
| 76420-948-30 | 76420094830 | 30 TABLET, FILM COATED in 1 BOTTLE (76420-948-30) | | 2025-04-08 | No | No | Historical |
| 76420-948-38 | 76420094838 | 10 BLISTER PACK in 1 CARTON (76420-948-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2025-04-08 | No | No | Historical |
| 76420-948-60 | 76420094860 | 60 TABLET, FILM COATED in 1 BOTTLE (76420-948-60) | | 2025-04-08 | No | No | Historical |
| 76420-948-90 | 76420094890 | 90 TABLET, FILM COATED in 1 BOTTLE (76420-948-90) | | 2025-04-08 | No | No | Historical |