CRESTOR
- Product NDC
- 43353-289
- 11-digit product format
- 433530289
- Labeler code
- 43353
- Product ID
- 43353-289_0291bd29-faa4-4aa9-83f6-7cb28c229413
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- NDA021366
- Marketing category
- NDA
- Marketing start
- 2003-08-18
- Marketing end
- 0000-00-00
- Substance
- ROSUVASTATIN CALCIUM
- Active strength
- 20 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- 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 |
|---|
| 43353-289-15 | CRESTOR | 15 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 15 | | 2 |
| 43353-289-17 | CRESTOR | 6030 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 6030 | | 2 |
| 43353-289-45 | CRESTOR | 45 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 45 | | 2 |
| 43353-289-91 | CRESTOR | 1260 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 1260 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ROSUVASTATIN CALCIUM | ACTIVE INGREDIENT | 83MVU38M7Q | CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| ROSUVASTATIN | ACTIVE MOIETY | 413KH5ZJ73 | CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| TRIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | 91D9GV0Z28 | CRESTOR (ROSUVASTATIN 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 |
|---|
| 43353-289 | CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | Legacy NDC, 4 package rows | 20140410_3ec57aa3-4399-46c9-9292-567d2a09df4f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 43353-289-15 | 43353028915 | 15 in 1 BOTTLE, PLASTIC | Historical |
| 43353-289-17 | 43353028917 | 6030 in 1 BOTTLE, PLASTIC | Historical |
| 43353-289-45 | 43353028945 | 45 in 1 BOTTLE, PLASTIC | Historical |
| 43353-289-91 | 43353028991 | 1260 in 1 BOTTLE, PLASTIC | Historical |