ATORVASTATIN CALCIUM
- Product NDC
- 82009-003
- 11-digit product format
- 820090003
- Labeler code
- 82009
- Product ID
- 82009-003_5c04b2a7-ceeb-a77b-fba1-ef8811d38669
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ATORVASTATIN CALCIUM
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Quallent
- Application
- ANDA090548
- Marketing category
- ANDA
- Marketing start
- 2021-11-23
- 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 | 259255, 617310, 617311, 617312 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82009-003-10 | ATORVASTATIN CALCIUM | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82009-003 | ATORVASTATIN CALCIUM TABLET, FILM COATED [QUALLENT] | 11 | Current NDC, Legacy NDC, 1 package rows | 20250411_f00a83aa-3f1d-566d-b9bb-f396f22a27cb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 82009-003-10 | 82009000310 | 1000 TABLET, FILM COATED in 1 BOTTLE (82009-003-10) | 2021-11-23 | 0000-00-00 | No | No | Current |