Rosuvastatin Calcium
- Product NDC
- 82804-176
- 11-digit product format
- 828040176
- Labeler code
- 82804
- Product ID
- 82804-176_dc7bfc79-9ee3-46e7-b55d-aba88648ad3b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA208898
- Marketing category
- ANDA
- Marketing start
- 2017-11-22
- Substance
- ROSUVASTATIN CALCIUM
- Active strength
- 40 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 | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 83MVU38M7Q |
| Rxcui | 859419 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82804-176-90 | Rosuvastatin Calcium | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82804-176 | ROSUVASTATIN CALCIUM TABLET, FILM COATED [PROFICIENT RX LP] | 1 | Current NDC, 1 package rows | 20241222_dc7bfc79-9ee3-46e7-b55d-aba88648ad3b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-176-90 | 82804017690 | 90 TABLET, FILM COATED in 1 BOTTLE (82804-176-90) | 2024-12-13 | No | No | Current |