Rosuvastatin Calcium
- Product NDC
- 60687-245
- 11-digit product format
- 606870245
- Labeler code
- 60687
- Product ID
- 60687-245_401aadf4-8665-4427-e063-6394a90a7820
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA079170
- Marketing category
- ANDA
- Marketing start
- 2016-09-26
- 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 | 859424, 859747, 859751 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60687-245-01 | Rosuvastatin Calcium | 100 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 100 | | 11 |
| 60687-245-11 | Rosuvastatin Calcium | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 11 |
| 60687-245-65 | Rosuvastatin Calcium | 50 in 1 CARTON | TABLET, FILM COATED | 50 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60687-245 | ROSUVASTATIN CALCIUM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 10 | Current NDC, Legacy NDC, 3 package rows | 20241218_b7491a1a-570e-40ea-b65b-f956c9e284a6.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 |
|---|
| 60687-245-01 | 60687024501 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-245-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-245-11) | 100 blister pack | 2016-09-26 | 0000-00-00 | No | No | Current |
| 60687-245-11 | 60687024511 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 60687-245-65 | 60687024565 | 50 BLISTER PACK in 1 CARTON (60687-245-65) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-245-11) | 50 blister pack | 2023-07-24 | | No | No | Historical |