ATORVASTATIN CALCIUM
- Product NDC
- 82868-029
- 11-digit product format
- 828680029
- Labeler code
- 82868
- Product ID
- 82868-029_46dca66b-0910-165c-e063-6294a90a1d9a
- 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
- 2023-11-30
- Substance
- ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE
- Active strength
- 40 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 PROPYLENE GLYCOL SOLVATE | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | YRZ789OWMI |
| Rxcui | 617311 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82868-029-30 | ATORVASTATIN CALCIUM | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82868-029 | ATORVASTATIN CALCIUM TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC] | 2 | Current NDC, 1 package rows | 20240704_0c5823ce-ed5c-356c-e063-6394a90aa15d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82868-029-30 | 82868002930 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-029-30) | 2023-11-30 | No | No | Current |