Rosuvastain Calcium
- Product NDC
- 62135-693
- 11-digit product format
- 621350693
- Labeler code
- 62135
- Product ID
- 62135-693_1d9afa7b-031d-18c5-e063-6294a90a6a7c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastain Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA079168
- Marketing category
- ANDA
- Marketing start
- 2016-07-19
- 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
- Rosuvastain 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, 859424, 859747, 859751 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-693-30 | Rosuvastain Calcium | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-693 | ROSUVASTAIN CALCIUM TABLET, FILM COATED [CHARTWELL RX, LLC] | 1 | Current NDC, 1 package rows | 20240720_a12a99ef-b573-498f-be5a-deb7cd538153.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 62135-693-30 | 62135069330 | 30 TABLET, FILM COATED in 1 BOTTLE (62135-693-30) | 2024-07-10 | No | No | Current |