ATORVASTATIN CALCIUM
- Product NDC
- 50268-094
- 11-digit product format
- 502680094
- Labeler code
- 50268
- Product ID
- 50268-094_4dc870e1-0b0c-9b87-e063-6294a90a1845
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ATORVASTATIN CALCIUM
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA090548
- Marketing category
- ANDA
- Marketing start
- 2016-06-28
- Substance
- ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE
- Active strength
- 20 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 | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | YRZ789OWMI |
| Rxcui | 259255, 617310, 617311, 617312 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50268-094-11 | ATORVASTATIN CALCIUM | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 10 |
| 50268-094-15 | ATORVASTATIN CALCIUM | 50 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 50 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50268-094 | ATORVASTATIN CALCIUM TABLET, FILM COATED [AVPAK] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240110_b687ba81-cb24-bbdf-5dd9-ab0e53dd480b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50268-094-11 | 50268009411 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 50268-094-15 | 50268009415 | 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-094-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-094-11) | 50 blister pack | 2016-06-28 | 0000-00-00 | No | No | Current |