Atorvastatin Calcium
- Product NDC
- 68788-8574
- 11-digit product format
- 687888574
- Labeler code
- 68788
- Product ID
- 68788-8574_1210ed88-c3f5-4e48-beaa-42d72fe16f29
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- atorvastatin calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA216436
- Marketing category
- ANDA
- Marketing start
- 2024-01-26
- Substance
- ATORVASTATIN CALCIUM TRIHYDRATE
- Active strength
- 40 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 | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 48A5M73Z4Q |
| Rxcui | 617311 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8574-9 | Atorvastatin Calcium | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8574 | ATORVASTATIN CALCIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] | 2 | Current NDC, 1 package rows | 20250207_2d9cb8d9-b367-464d-9bcd-6de8de2b6c23.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8574-9 | 68788857409 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8574-9) | 2024-01-26 | No | No | Historical |