Rosuvastatin
- Product NDC
- 50228-118
- 11-digit product format
- 502280118
- Labeler code
- 50228
- Product ID
- 50228-118_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
- 20 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 | 20 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 |
|---|---|---|---|---|---|---|
| 50228-118-05 | Rosuvastatin | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | 9 | |
| 50228-118-10 | Rosuvastatin | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 9 | |
| 50228-118-30 | Rosuvastatin | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 9 | |
| 50228-118-90 | 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 |
|---|---|---|---|---|---|
| 50228-118-05 | EA - Each | 50228-118 | 065b34c3-49e4-450b-a5a7-aa229ec22ad6 | 1 | 2024-02-14 |
| 50228-118-10 | EA - Each | 50228-118 | 20bb01d2-a1e8-469a-a28c-fa95ed9eeda9 | 1 | 2024-02-14 |
| 50228-118-90 | EA - Each | 50228-118 | 4991c035-0958-48bb-9723-22dd76e2694c | 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 |
| 859751 | rosuvastatin calcium 20 MG Oral Tablet | PSN | ab8f6264-cf12-4523-92f1-2bd60b3da442 | 5 |
| 859751 | rosuvastatin calcium 20 MG Oral Tablet | SCD | ab8f6264-cf12-4523-92f1-2bd60b3da442 | 5 |
| 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 |
| 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 | 0f02c184-49f3-8fa6-e063-6394a90a5092 | 3 |
| 859751 | rosuvastatin calcium 20 MG Oral Tablet | PSN | cc9c9664-2601-4dff-843b-1e96f6c8a70a | 2 |
| 859751 | rosuvastatin calcium 20 MG Oral Tablet | PSN | d91dd29a-bb29-4193-a849-840f8696f658 | 2 |
| 859751 | rosuvastatin calcium 20 MG Oral Tablet | SCD | cc9c9664-2601-4dff-843b-1e96f6c8a70a | 2 |
| 859751 | rosuvastatin calcium 20 MG Oral Tablet | SCD | d91dd29a-bb29-4193-a849-840f8696f658 | 2 |
| 859751 | rosuvastatin calcium 20 MG Oral Tablet | PSN | 81910817-f976-4936-ae31-d211083d249b | 1 |
| 859751 | rosuvastatin calcium 20 MG Oral Tablet | PSN | 771d3591-ecca-43de-a0f3-c72adb8543f5 | 1 |
| 859751 | rosuvastatin calcium 20 MG Oral Tablet | PSN | 3982830d-3cda-e636-e063-6394a90a1eb1 | 1 |
| 859751 | rosuvastatin calcium 20 MG Oral Tablet | PSN | 351ee6c1-3e31-3f87-e063-6394a90a47c7 | 1 |
| 859751 | rosuvastatin calcium 20 MG Oral Tablet | SCD | 81910817-f976-4936-ae31-d211083d249b | 1 |
| 859751 | rosuvastatin calcium 20 MG Oral Tablet | SCD | 771d3591-ecca-43de-a0f3-c72adb8543f5 | 1 |
| 859751 | rosuvastatin calcium 20 MG Oral Tablet | SCD | 3982830d-3cda-e636-e063-6394a90a1eb1 | 1 |
| 859751 | rosuvastatin calcium 20 MG Oral Tablet | SCD | 351ee6c1-3e31-3f87-e063-6394a90a47c7 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50228-118-05 | 50228011805 | 500 TABLET, FILM COATED in 1 BOTTLE (50228-118-05) | 2023-09-07 | No | No | Historical | |
| 50228-118-10 | 50228011810 | 1000 TABLET, FILM COATED in 1 BOTTLE (50228-118-10) | 2019-04-24 | 0000-00-00 | No | No | Current |
| 50228-118-30 | 50228011830 | 30 TABLET, FILM COATED in 1 BOTTLE (50228-118-30) | 2019-04-24 | 0000-00-00 | No | No | Current |
| 50228-118-90 | 50228011890 | 90 TABLET, FILM COATED in 1 BOTTLE (50228-118-90) | 2019-04-24 | 0000-00-00 | No | No | Current |