Rosuvastatin
- Product NDC
- 50228-116
- 11-digit product format
- 502280116
- Labeler code
- 50228
- Product ID
- 50228-116_2fb0db87-33a8-e6a1-e063-6294a90a5b4a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- ScieGen Pharmaceuticals, Inc.
- Application
- ANDA206381
- Marketing category
- ANDA
- Marketing start
- 2019-04-24
- Substance
- ROSUVASTATIN
- Active strength
- 5 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
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ROSUVASTATIN | 5 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 413KH5ZJ73 |
| Rxcui | 859419, 859424, 859747, 859751 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c8f25656-847a-4de8-96a7-06bf98d83c2b | Product name | 1 | 20210916 |
| b6a872b4-e31a-fff0-6f62-fd0253265e2f | Product name | 9 | 20190618 |
| 5a2818e5-ef92-49b1-bc6c-9fe2427d21d5 | Product name | 1 | 20190429 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50228-116-05 | Rosuvastatin | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | 9 | |
| 50228-116-10 | Rosuvastatin | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 9 | |
| 50228-116-30 | Rosuvastatin | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 9 | |
| 50228-116-90 | Rosuvastatin | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50228-116-05 | EA - Each | 50228-116 | e57d7ba5-8a89-4931-9131-4fff284ddb33 | 1 | 2024-02-14 |
| 50228-116-10 | EA - Each | 50228-116 | c867c4c0-2498-42c6-956d-4c529ec286cf | 1 | 2024-02-14 |
| 50228-116-90 | EA - Each | 50228-116 | 9ae220e0-51e7-4d3f-aba9-7a23a8424de6 | 1 | 2024-02-14 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 859747 | rosuvastatin calcium 10 MG Oral Tablet | PSN | ee4933c5-0d97-494d-ac0f-2083e0100836 | 9 |
| 859751 | rosuvastatin calcium 20 MG Oral Tablet | PSN | ee4933c5-0d97-494d-ac0f-2083e0100836 | 9 |
| 859419 | rosuvastatin calcium 40 MG Oral Tablet | PSN | ee4933c5-0d97-494d-ac0f-2083e0100836 | 9 |
| 859424 | rosuvastatin calcium 5 MG Oral Tablet | PSN | ee4933c5-0d97-494d-ac0f-2083e0100836 | 9 |
| 859747 | rosuvastatin calcium 10 MG Oral Tablet | SCD | ee4933c5-0d97-494d-ac0f-2083e0100836 | 9 |
| 859751 | rosuvastatin calcium 20 MG Oral Tablet | SCD | ee4933c5-0d97-494d-ac0f-2083e0100836 | 9 |
| 859419 | rosuvastatin calcium 40 MG Oral Tablet | SCD | ee4933c5-0d97-494d-ac0f-2083e0100836 | 9 |
| 859424 | rosuvastatin calcium 5 MG Oral Tablet | SCD | ee4933c5-0d97-494d-ac0f-2083e0100836 | 9 |
| 859747 | rosuvastatin calcium 10 MG Oral Tablet | PSN | 0f02c184-49f3-8fa6-e063-6394a90a5092 | 3 |
| 859751 | rosuvastatin calcium 20 MG Oral Tablet | PSN | 0f02c184-49f3-8fa6-e063-6394a90a5092 | 3 |
| 859419 | rosuvastatin calcium 40 MG Oral Tablet | PSN | 0f02c184-49f3-8fa6-e063-6394a90a5092 | 3 |
| 859424 | rosuvastatin calcium 5 MG Oral Tablet | PSN | 0f02c184-49f3-8fa6-e063-6394a90a5092 | 3 |
| 859424 | rosuvastatin calcium 5 MG Oral Tablet | PSN | a2ac073e-4d9a-4b0a-8698-a06d73dc6962 | 3 |
| 859424 | rosuvastatin calcium 5 MG Oral Tablet | PSN | 6ebaefa9-2c71-4777-8730-83cf5ae737cc | 3 |
| 859424 | rosuvastatin calcium 5 MG Oral Tablet | PSN | 4cbafae0-c316-4f28-8c95-b831cab9a0eb | 3 |
| 859747 | rosuvastatin calcium 10 MG Oral Tablet | SCD | 0f02c184-49f3-8fa6-e063-6394a90a5092 | 3 |
| 859751 | rosuvastatin calcium 20 MG Oral Tablet | SCD | 0f02c184-49f3-8fa6-e063-6394a90a5092 | 3 |
| 859419 | rosuvastatin calcium 40 MG Oral Tablet | SCD | 0f02c184-49f3-8fa6-e063-6394a90a5092 | 3 |
| 859424 | rosuvastatin calcium 5 MG Oral Tablet | SCD | a2ac073e-4d9a-4b0a-8698-a06d73dc6962 | 3 |
| 859424 | rosuvastatin calcium 5 MG Oral Tablet | SCD | 6ebaefa9-2c71-4777-8730-83cf5ae737cc | 3 |
| 859424 | rosuvastatin calcium 5 MG Oral Tablet | SCD | 4cbafae0-c316-4f28-8c95-b831cab9a0eb | 3 |
| 859424 | rosuvastatin calcium 5 MG Oral Tablet | SCD | 0f02c184-49f3-8fa6-e063-6394a90a5092 | 3 |
| 859424 | rosuvastatin calcium 5 MG Oral Tablet | PSN | 4ba31486-c9e7-4361-b658-5464dc9ebc14 | 2 |
| 859424 | rosuvastatin calcium 5 MG Oral Tablet | SCD | 4ba31486-c9e7-4361-b658-5464dc9ebc14 | 2 |
| 859747 | rosuvastatin calcium 10 MG Oral Tablet | PSN | d4396def-5692-48ef-b3ab-f0ab2baadf27 | 1 |
| 859424 | rosuvastatin calcium 5 MG Oral Tablet | PSN | d4396def-5692-48ef-b3ab-f0ab2baadf27 | 1 |
| 859747 | rosuvastatin calcium 10 MG Oral Tablet | SCD | d4396def-5692-48ef-b3ab-f0ab2baadf27 | 1 |
| 859424 | rosuvastatin calcium 5 MG Oral Tablet | SCD | d4396def-5692-48ef-b3ab-f0ab2baadf27 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50228-116-05 | 50228011605 | 500 TABLET, FILM COATED in 1 BOTTLE (50228-116-05) | 2023-09-07 | No | No | Historical | |
| 50228-116-10 | 50228011610 | 1000 TABLET, FILM COATED in 1 BOTTLE (50228-116-10) | 2019-04-24 | 0000-00-00 | No | No | Current |
| 50228-116-30 | 50228011630 | 30 TABLET, FILM COATED in 1 BOTTLE (50228-116-30) | 2019-04-24 | 0000-00-00 | No | No | Current |
| 50228-116-90 | 50228011690 | 90 TABLET, FILM COATED in 1 BOTTLE (50228-116-90) | 2019-04-24 | 0000-00-00 | No | No | Current |