Rosuvastatin
- Product NDC
- 68788-4161
- 11-digit product format
- 687884161
- Labeler code
- 68788
- Product ID
- 68788-4161_88fd44de-f2c4-4541-a859-bb9553da9674
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA206381
- Marketing category
- ANDA
- Marketing start
- 2026-07-22
- 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
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206381-001 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2019-04-24 | |
| A206381-002 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2019-04-24 | |
| A206381-003 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2019-04-24 | |
| A206381-004 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2019-04-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A206381-001 | AB |
| A206381-002 | AB |
| A206381-003 | AB |
| A206381-004 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A206381-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2019-04-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A206381-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2019-04-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A206381-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2019-04-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A206381-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2019-04-24 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A206381-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2019-04-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A206381-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2019-04-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A206381-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2019-04-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A206381-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2019-04-24 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206381-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2019-04-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206381-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2019-04-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206381-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2019-04-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206381-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2019-04-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206381-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2019-04-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206381-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2019-04-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206381-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2019-04-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206381-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2019-04-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206381-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2019-04-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206381-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2019-04-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206381-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2019-04-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206381-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2019-04-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206381-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2019-04-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206381-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2019-04-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206381-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2019-04-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206381-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2019-04-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206381-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2019-04-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206381-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2019-04-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206381-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2019-04-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206381-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2019-04-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206381-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2019-04-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206381-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2019-04-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206381-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2019-04-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206381-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2019-04-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206381-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2019-04-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206381-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2019-04-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206381-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2019-04-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206381-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2019-04-24 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206381-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2019-04-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206381-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2019-04-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206381-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2019-04-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206381-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2019-04-24 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A206381-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A206381-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A206381-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A206381-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A206381-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A206381-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A206381-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A206381-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A206381-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206381-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206381-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206381-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206381-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206381-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206381-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206381-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A206381-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206381-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206381-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206381-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206381-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206381-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206381-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206381-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206381-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206381-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206381-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206381-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206381-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206381-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206381-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206381-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206381-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206381-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206381-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206381-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206381-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206381-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206381-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206381-004 | AB | 1 | 5bbf6a4d5a75… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Rosuvastatin
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ROSUVASTATIN | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 413KH5ZJ73 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 859424 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 88fd44de-f2c4-4541-a859-bb9553da9674 | Available on FDA.report |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Rosuvastatin | ROSUVASTATIN | ScieGen Pharmaceuticals, Inc. | ee4933c5-0d97-494d-ac0f-2083e0100836 | 2026-09-04 | Warnings, Adverse reactions | 206381 ANDA206381 |
| Rosuvastatin | ROSUVASTATIN | REMEDYREPACK INC. | a370a6c2-b5cd-4aa0-b072-a5a8017a2d5b | 2026-09-04 | Warnings, Adverse reactions | 206381 ANDA206381 |
| Rosuvastatin | ROSUVASTATIN | REMEDYREPACK INC. | ab8f6264-cf12-4523-92f1-2bd60b3da442 | 2026-09-03 | Warnings, Adverse reactions | 206381 ANDA206381 |
| Rosuvastatin | ROSUVASTATIN | REMEDYREPACK INC. | b8b29392-85fa-417b-bd10-10ab0d07381f | 2026-09-03 | Warnings, Adverse reactions | 206381 ANDA206381 |
| Rosuvastatin | ROSUVASTATIN | REMEDYREPACK INC. | 6ebaefa9-2c71-4777-8730-83cf5ae737cc | 2026-08-27 | Warnings, Adverse reactions | 206381 ANDA206381 |
| Rosuvastatin | ROSUVASTATIN | Preferred Pharmaceuticals Inc. | d91dd29a-bb29-4193-a849-840f8696f658 | 2026-08-26 | Warnings, Adverse reactions | 206381 ANDA206381 |
| Rosuvastatin | ROSUVASTATIN | Preferred Pharmaceuticals Inc. | 88fd44de-f2c4-4541-a859-bb9553da9674 | 2026-07-22 | Warnings, Adverse reactions | 206381 ANDA206381 68788-4161 |
| Rosuvastatin | ROSUVASTATIN | A-S Medication Solutions | a2ac073e-4d9a-4b0a-8698-a06d73dc6962 | 2026-01-15 | Warnings, Adverse reactions | 206381 ANDA206381 |
| Rosuvastatin | ROSUVASTATIN | A-S Medication Solutions | 4cbafae0-c316-4f28-8c95-b831cab9a0eb | 2026-01-15 | Warnings, Adverse reactions | 206381 ANDA206381 |
| Rosuvastatin | ROSUVASTATIN | Coupler LLC | 46173656-d889-ec14-e063-6294a90aae81 | 2025-12-16 | Warnings, Adverse reactions | 206381 ANDA206381 |
| Rosuvastatin | ROSUVASTATIN | A-S Medication Solutions | 771d3591-ecca-43de-a0f3-c72adb8543f5 | 2025-11-26 | Warnings, Adverse reactions | 206381 ANDA206381 |
| Rosuvastatin | ROSUVASTATIN | Preferred Pharmaceuticals Inc. | 26d14bab-ee7c-49fe-9fb0-8426a589b599 | 2025-11-24 | Warnings, Adverse reactions | 206381 ANDA206381 |
| Rosuvastatin | ROSUVASTATIN | A-S Medication Solutions | 81910817-f976-4936-ae31-d211083d249b | 2025-11-01 | Warnings, Adverse reactions | 206381 ANDA206381 |
| Rosuvastatin | ROSUVASTATIN | A-S Medication Solutions | 3153ba21-6314-4d1c-a8f1-9ae7a99c2a1a | 2025-10-10 | Warnings, Adverse reactions | 206381 ANDA206381 |
| Rosuvastatin | ROSUVASTATIN | A-S Medication Solutions | adf5df0d-a2e8-4c75-b8fd-15351f4223e9 | 2025-10-10 | Warnings, Adverse reactions | 206381 ANDA206381 |
| Rosuvastatin | ROSUVASTATIN | A-S Medication Solutions | f201a404-9170-4684-a988-0c0aedcd2ddb | 2025-10-10 | Warnings, Adverse reactions | 206381 ANDA206381 |
| Rosuvastatin | ROSUVASTATIN | Aphena Pharma Solutions - Tennessee, LLC | 3982830d-3cda-e636-e063-6394a90a1eb1 | 2025-07-09 | Warnings, Adverse reactions | 206381 ANDA206381 |
| Rosuvastatin | ROSUVASTATIN | NuCare Pharmaceuticals, Inc. | 351ee6c1-3e31-3f87-e063-6394a90a47c7 | 2025-05-14 | Warnings, Adverse reactions | 206381 ANDA206381 |
| Rosuvastatin | ROSUVASTATIN | Golden State Medical Supply, Inc. | 0f02c184-49f3-8fa6-e063-6394a90a5092 | 2025-04-15 | Warnings, Adverse reactions | 206381 ANDA206381 |
| Rosuvastatin | ROSUVASTATIN | A-S Medication Solutions | b7f943f4-35da-4aa7-a4fc-810b914748bf | 2024-12-30 | Warnings, Adverse reactions | 206381 ANDA206381 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 68788-4161-3 | 68788416103 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-4161-3) | 2026-07-22 | No | No | Current |
| 68788-4161-6 | 68788416106 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-4161-6) | 2026-07-22 | No | No | Current |
| 68788-4161-9 | 68788416109 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-4161-9) | 2026-07-22 | No | No | Current |