ATORVASTATIN CALCIUM
- Product NDC
- 51655-613
- 11-digit product format
- 516550613
- Labeler code
- 51655
- Product ID
- 51655-613_494f2b48-27b0-0214-e063-6394a90a8f2f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ATORVASTATIN CALCIUM
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA090548
- Marketing category
- ANDA
- Marketing start
- 2022-11-15
- Substance
- ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE
- 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 PROPYLENE GLYCOL SOLVATE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | YRZ789OWMI |
| Rxcui | 617312 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51655-613-52 | ATORVASTATIN CALCIUM | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 3 |
| 51655-613-83 | ATORVASTATIN CALCIUM | 180 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 180 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-613 | ATORVASTATIN CALCIUM TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC] | 2 | Current NDC, 2 package rows | 20240725_f32c8a4f-dee9-86a0-e053-2995a90a3388.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 51655-613-52 | 51655061352 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-613-52) | 2022-11-15 | No | No | Current |
| 51655-613-83 | 51655061383 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-613-83) | 2023-02-15 | No | No | Current |