Atorvastatin Calcium
- Product NDC
- 68071-3580
- 11-digit product format
- 680713580
- Labeler code
- 68071
- Product ID
- 68071-3580_12750e3b-b423-09d6-e063-6394a90a5b3f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- atorvastatin calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA216436
- Marketing category
- ANDA
- Marketing start
- 2023-03-01
- 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
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 | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 48A5M73Z4Q |
| Rxcui | 617310 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3580-9 | Atorvastatin Calcium | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3580 | ATORVASTATIN CALCIUM TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] | 1 | Current NDC, 1 package rows | 20240301_12751ca4-cde3-92dd-e063-6294a90a4e9d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3580-9 | 68071358009 | 90 TABLET, FILM COATED in 1 BOTTLE (68071-3580-9) | 2024-02-28 | No | No | Current |