Rosuvastatin Calcium
- Product NDC
- 68788-7947
- Requested package NDC
- 68788-7947-9
- 11-digit product format
- 687887947
- Labeler code
- 68788
- Product ID
- 68788-7947_6a9ce067-37a9-494b-95ec-62fd92ce5c0a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA206465
- Marketing category
- ANDA
- Marketing start
- 2021-06-29
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 68788-7947 | 68788-7947-9 | D | Discontinued by firm | 2026-08-17 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206465-001 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2017-03-21 | |
| A206465-002 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2017-03-21 | |
| A206465-003 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2017-03-21 | |
| A206465-004 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2017-03-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A206465-001 | AB |
| A206465-002 | AB |
| A206465-003 | AB |
| A206465-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A206465-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2017-03-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A206465-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2017-03-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A206465-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2017-03-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A206465-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2017-03-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206465-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2017-03-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206465-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2017-03-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206465-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2017-03-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206465-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2017-03-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206465-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2017-03-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206465-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2017-03-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206465-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2017-03-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206465-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2017-03-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206465-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2017-03-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206465-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2017-03-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206465-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2017-03-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206465-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2017-03-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206465-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2017-03-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206465-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2017-03-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206465-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2017-03-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206465-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2017-03-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206465-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2017-03-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206465-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2017-03-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206465-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2017-03-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206465-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2017-03-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206465-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2017-03-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206465-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2017-03-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206465-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2017-03-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206465-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2017-03-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206465-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2017-03-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206465-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2017-03-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206465-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2017-03-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206465-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2017-03-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206465-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2017-03-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206465-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2017-03-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206465-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2017-03-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206465-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2017-03-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206465-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2017-03-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206465-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2017-03-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206465-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2017-03-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206465-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2017-03-21 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A206465-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A206465-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A206465-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A206465-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A206465-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206465-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206465-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206465-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206465-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206465-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206465-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206465-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A206465-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206465-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206465-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206465-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206465-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206465-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206465-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206465-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206465-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206465-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206465-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206465-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206465-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206465-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206465-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206465-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206465-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206465-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206465-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206465-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206465-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206465-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206465-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206465-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206465-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206465-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206465-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206465-004 | AB | 1 | d8e5a09893c0… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-7947-2 | EA - Each | 68788-7947 | dd507e39-84f8-42ac-a1b1-374c91294a4e | 1 | 2021-07-15 |
| 68788-7947-3 | EA - Each | 68788-7947 | 1c864b9a-4d30-436e-a5af-f1cc6eebcf2c | 1 | 2021-07-15 |
| 68788-7947-6 | EA - Each | 68788-7947 | e814f20f-5f77-4c73-888f-b1872dc774ae | 1 | 2021-07-15 |
| 68788-7947-9 | EA - Each | 68788-7947 | b1782d05-e989-4b7c-a59e-361cb5f407a1 | 1 | 2021-07-15 |
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 Calcium | ROSUVASTATIN CALCIUM | Bryant Ranch Prepack | 67da041b-7ad5-4309-86b3-8c30a5f9465e | 2026-05-27 | Warnings, Adverse reactions | 206465 ANDA206465 |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | NuCare Pharmaceuticals,Inc. | c2d9a04e-8c72-d487-e053-2a95a90a0fcd | 2026-03-26 | Warnings, Adverse reactions | 206465 ANDA206465 |
| Rosuvastatin | ROSUVASTATIN | Quallent Pharmaceuticals Health LLC | 0d12ae85-71bd-4818-a82d-fd068530bd87 | 2026-01-19 | Warnings, Adverse reactions | 206465 ANDA206465 |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | Northwind Health Company, LLC | e08b4f88-0713-1141-e053-2a95a90ae7b5 | 2026-01-01 | Warnings, Adverse reactions | 206465 ANDA206465 |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | Ascend Laboratories, LLC | 4ccbaa83-d57a-421e-88a8-1cee42d4207b | 2025-12-23 | Warnings, Adverse reactions | 206465 ANDA206465 |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | A-S Medication Solutions | 7b2fc012-bf45-4a27-9e48-67926972918d | 2023-09-10 | Warnings, Adverse reactions | 206465 ANDA206465 |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | Proficient Rx LP | 76bbea68-52d8-4ba9-a772-0ba75a38f2eb | 2023-07-01 | Warnings, Adverse reactions | 206465 ANDA206465 |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | A-S Medication Solutions | 0514e340-54a7-470c-8072-c8113fddf2d9 | 2023-04-19 | Warnings, Adverse reactions | 206465 ANDA206465 |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | A-S Medication Solutions | ac89adcd-3226-4a66-8902-0f0a33be159a | 2023-03-15 | Warnings, Adverse reactions | 206465 ANDA206465 |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | A-S Medication Solutions | 3aa55393-11c9-4c31-8697-ecaad8c78857 | 2023-02-06 | Warnings, Adverse reactions | 206465 ANDA206465 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68788-7947-9 | 68788794709 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-7947-9) | 2021-06-29 | 0000-00-00 | No | No | Current |