ATORVASTATIN CALCIUM
- Product NDC
- 70518-4550
- 11-digit product format
- 705184550
- Labeler code
- 70518
- Product ID
- 70518-4550_48d20cf1-5a59-d787-e063-6294a90ac997
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ATORVASTATIN CALCIUM
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA214344
- Marketing category
- ANDA
- Marketing start
- 2026-01-19
- Substance
- ATORVASTATIN CALCIUM TRIHYDRATE
- Active strength
- 10 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ATORVASTATIN CALCIUM
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ATORVASTATIN CALCIUM TRIHYDRATE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 48A5M73Z4Q |
| Rxcui | 617312 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4550-0 | ATORVASTATIN CALCIUM | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4550-0 | 70518455000 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4550-0) | 2026-01-19 | No | No | Historical |