Rosuvastatin Calcium
- Product NDC
- 69367-361
- 11-digit product format
- 693670361
- Labeler code
- 69367
- Product ID
- 69367-361_447c034b-bd46-2a37-e063-6394a90a4feb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Westminster Pharmaceuticals, LLC
- Application
- ANDA207062
- Marketing category
- ANDA
- Marketing start
- 2024-12-01
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Rosuvastatin Calcium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ROSUVASTATIN CALCIUM | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 83MVU38M7Q |
| Rxcui | 859419, 859424, 859747, 859751 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69367-361-01 | Rosuvastatin Calcium | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 6 |
| 69367-361-05 | Rosuvastatin Calcium | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 6 |
| 69367-361-09 | Rosuvastatin Calcium | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 6 |
| 69367-361-10 | Rosuvastatin Calcium | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 6 |
| 69367-361-30 | Rosuvastatin Calcium | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69367-361 | ROSUVASTATIN CALCIUM TABLET, FILM COATED [WESTMINSTER PHARMACEUTICALS, LLC] | 3 | Current NDC, 5 package rows | 20241202_02797697-300a-43db-92cf-9b78f08626be.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 69367-361-01 | 69367036101 | 100 TABLET, FILM COATED in 1 BOTTLE (69367-361-01) | 2024-12-01 | No | No | Current |
| 69367-361-05 | 69367036105 | 500 TABLET, FILM COATED in 1 BOTTLE (69367-361-05) | 2024-12-01 | No | No | Current |
| 69367-361-09 | 69367036109 | 90 TABLET, FILM COATED in 1 BOTTLE (69367-361-09) | 2024-12-01 | No | No | Current |
| 69367-361-10 | 69367036110 | 1000 TABLET, FILM COATED in 1 BOTTLE (69367-361-10) | 2024-12-01 | No | No | Current |
| 69367-361-30 | 69367036130 | 30 TABLET, FILM COATED in 1 BOTTLE (69367-361-30) | 2024-12-01 | No | No | Current |