ROSUVASTATIN CALCIUM
- Product NDC
- 76519-1162
- 11-digit product format
- 765191162
- Labeler code
- 76519
- Product ID
- 76519-1162_5f248416-c8f9-98b2-e053-2991aa0aa855
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ROSUVASTATIN CALCIUM
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- H. J. Harkins Company Inc.
- Application
- ANDA079171
- Marketing category
- ANDA
- Marketing start
- 2017-01-03
- Marketing end
- 0000-00-00
- Substance
- ROSUVASTATIN CALCIUM
- Active strength
- 10 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 |
|---|
| 76519-1162-9 | ROSUVASTATIN CALCIUM | 90 in 1 CONTAINER | TABLET, FILM COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76519-1162 | ROSUVASTATIN CALCIUM TABLET, FILM COATED [H. J. HARKINS COMPANY INC.] | 1 | Legacy NDC, 1 package rows | 20171130_5f248416-c8f8-98b2-e053-2991aa0aa855.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 76519-1162-9 | 76519116209 | 90 in 1 CONTAINER | Historical |