ATORVASTATIN CALCIUM
- Product NDC
- 0615-8009
- 11-digit product format
- 006158009
- Labeler code
- 0615
- Product ID
- 0615-8009_77d8e3d2-c909-4c76-9572-f838179cd722
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ATORVASTATIN CALCIUM
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA090548
- Marketing category
- ANDA
- Marketing start
- 2012-05-29
- Substance
- ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE
- Active strength
- 80 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 | 80 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | YRZ789OWMI |
| Rxcui | 259255, 617310 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8009-05 | ATORVASTATIN CALCIUM | 15 in 1 BLISTER PACK | TABLET, FILM COATED | 15 | | 34 |
| 0615-8009-07 | ATORVASTATIN CALCIUM | 7 in 1 BLISTER PACK | TABLET, FILM COATED | 7 | | 34 |
| 0615-8009-39 | ATORVASTATIN CALCIUM | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 34 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8009 | ATORVASTATIN CALCIUM TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 33 | Current NDC, Legacy NDC, 3 package rows | 20250119_7353f9ef-6f79-4522-886a-7a8ae4eb867e.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 |
|---|
| 0615-8009-05 | 00615800905 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8009-05) | 2012-05-29 | 0000-00-00 | No | No | Current |
| 0615-8009-07 | 00615800907 | 7 TABLET, FILM COATED in 1 BLISTER PACK (0615-8009-07) | 2023-08-17 | | No | No | Historical |
| 0615-8009-39 | 00615800939 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8009-39) | 2012-05-29 | 0000-00-00 | No | No | Current |