Rosuvastatin Calcium
- Product NDC
- 72205-003
- 11-digit product format
- 722050003
- Labeler code
- 72205
- Product ID
- 72205-003_62787a4a-6d53-43a3-a0b7-ed0b6037d18e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Novadoz Pharmaceuticals LLC
- Application
- ANDA208898
- Marketing category
- ANDA
- Marketing start
- 2017-11-22
- 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
- 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 | 10 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 |
|---|
| 72205-003-05 | Rosuvastatin Calcium | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 9 |
| 72205-003-06 | Rosuvastatin Calcium | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 9 |
| 72205-003-11 | Rosuvastatin Calcium | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 9 |
| 72205-003-90 | Rosuvastatin Calcium | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 9 |
| 72205-003-99 | Rosuvastatin Calcium | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72205-003 | ROSUVASTATIN CALCIUM TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC] | 9 | Current NDC, Legacy NDC, 5 package rows | 20250302_d58f1f63-4bb6-413c-9730-ded3e8078618.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 |
|---|
| 72205-003-05 | 72205000305 | 500 TABLET, FILM COATED in 1 BOTTLE (72205-003-05) | | 2019-02-25 | 0000-00-00 | No | No | Current |
| 72205-003-06 | 72205000306 | 100 BLISTER PACK in 1 CARTON (72205-003-06) / 10 TABLET, FILM COATED in 1 BLISTER PACK (72205-003-11) | 100 blister pack | 2017-11-22 | 0000-00-00 | No | No | Current |
| 72205-003-11 | 72205000311 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 72205-003-90 | 72205000390 | 90 TABLET, FILM COATED in 1 BOTTLE (72205-003-90) | | 2017-11-22 | 0000-00-00 | No | No | Current |
| 72205-003-99 | 72205000399 | 1000 TABLET, FILM COATED in 1 BOTTLE (72205-003-99) | | 2017-11-22 | 0000-00-00 | No | No | Current |