ATORVASTATIN CALCIUM
- Product NDC
- 43353-826
- 11-digit product format
- 433530826
- Labeler code
- 43353
- Product ID
- 43353-826_cdb75f3a-bd50-4718-bdd3-0bd3cff8117f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ATORVASTATIN CALCIUM
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- NDA020702
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2011-11-30
- Marketing end
- 0000-00-00
- Substance
- ATORVASTATIN CALCIUM TRIHYDRATE
- Active strength
- 40 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 43353-826-15 | ATORVASTATIN CALCIUM | 15 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 15 | | 4 |
| 43353-826-30 | ATORVASTATIN CALCIUM | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 4 |
| 43353-826-45 | ATORVASTATIN CALCIUM | 45 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 45 | | 4 |
| 43353-826-60 | ATORVASTATIN CALCIUM | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ATORVASTATIN CALCIUM TRIHYDRATE | ACTIVE INGREDIENT | 48A5M73Z4Q | ATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| ATORVASTATIN | ACTIVE MOIETY | A0JWA85V8F | ATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| CALCIUM CARBONATE | INACTIVE INGREDIENT | H0G9379FGK | ATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| CANDELILLA WAX | INACTIVE INGREDIENT | WL0328HX19 | ATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | ATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | ATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | ATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-826 | ATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 4 | Legacy NDC, 4 package rows | 20191221_1b1faadc-b8b5-4545-a12b-060a90881aec.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 |
|---|
| 43353-826-15 | 43353082615 | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-826-15) | 2013-03-11 | 0000-00-00 | No | No | Current |
| 43353-826-30 | 43353082630 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-826-30) | 2013-03-11 | 0000-00-00 | No | No | Current |
| 43353-826-45 | 43353082645 | 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-826-45) | 2013-03-11 | 0000-00-00 | No | No | Current |
| 43353-826-60 | 43353082660 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-826-60) | 2015-07-09 | 0000-00-00 | No | No | Current |