Rosuvastatin
- Product NDC
- 68788-7971
- 11-digit product format
- 687887971
- Labeler code
- 68788
- Product ID
- 68788-7971_7014a4df-8c38-4de7-87a3-8d35fe26fcc1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA206434
- Marketing category
- ANDA
- Marketing start
- 2021-07-21
- Marketing end
- 0000-00-00
- Substance
- ROSUVASTATIN CALCIUM
- Active strength
- 5 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 product | product | 68788-7971 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 68788-7971 | 68788-7971-3 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 68788-7971 | 68788-7971-6 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 68788-7971 | 68788-7971-9 | 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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-7971-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-7971-6 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-7971-9 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-7971-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-7971-6 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-7971-9 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68788-7971-3 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68788-7971-6 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68788-7971-9 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68788-7971-3 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68788-7971-6 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68788-7971-9 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68788-7971-3 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68788-7971-6 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68788-7971-9 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68788-7971-3 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68788-7971-6 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68788-7971-9 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68788-7971-3 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68788-7971-6 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68788-7971-9 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68788-7971-3 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68788-7971-6 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68788-7971-9 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68788-7971-3 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68788-7971-6 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68788-7971-9 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68788-7971-3 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68788-7971-6 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68788-7971-9 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 68788-7971-3 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 68788-7971-6 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 68788-7971-9 | 367a005e9d99… | 383a685ebd0f… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206434-001 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-10-31 | |
| A206434-002 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-10-31 | |
| A206434-003 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-10-31 | |
| A206434-004 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-10-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A206434-001 | AB |
| A206434-002 | AB |
| A206434-003 | AB |
| A206434-004 | 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 | A206434-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-10-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A206434-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-10-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A206434-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-10-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A206434-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-10-31 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206434-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-10-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206434-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-10-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206434-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-10-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206434-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-10-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206434-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-10-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206434-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-10-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206434-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-10-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206434-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-10-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206434-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-10-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206434-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-10-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206434-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-10-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206434-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-10-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206434-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-10-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206434-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-10-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206434-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-10-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206434-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-10-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206434-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-10-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206434-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-10-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206434-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-10-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206434-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-10-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206434-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-10-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206434-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-10-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206434-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-10-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206434-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-10-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206434-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-10-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206434-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-10-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206434-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-10-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206434-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-10-31 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206434-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-10-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206434-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-10-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206434-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-10-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206434-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-10-31 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206434-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-10-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206434-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-10-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206434-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-10-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206434-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-10-31 | 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 | A206434-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A206434-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A206434-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A206434-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A206434-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206434-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206434-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206434-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206434-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206434-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206434-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206434-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A206434-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206434-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206434-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206434-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206434-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206434-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206434-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206434-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206434-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206434-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206434-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206434-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206434-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206434-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206434-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206434-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206434-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206434-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206434-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206434-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206434-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206434-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206434-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206434-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206434-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206434-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206434-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206434-004 | AB | 1 | d8e5a09893c0… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-7971-3 | EA - Each | 68788-7971 | fe9d72ed-e022-4dab-969b-9ce27319cb01 | 1 | 2021-08-05 |
| 68788-7971-6 | EA - Each | 68788-7971 | fc49691c-eb7a-4a2b-9bd3-a3d1820eccdc | 1 | 2021-08-05 |
| 68788-7971-9 | EA - Each | 68788-7971 | eb19d76f-be5e-4264-ab6b-07c09b67fa7e | 1 | 2021-08-05 |
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 | bf40166a-4f73-47ff-938b-2bdbf7f000e4 | 2026-05-19 | Warnings, Adverse reactions | 206434 ANDA206434 |
| Rosuvastatin | ROSUVASTATIN | Accord Healthcare Inc. | 3ffe0294-3997-2755-e054-00144ff8d46c | 2025-11-14 | Warnings, Adverse reactions | 206434 ANDA206434 |
| Rosuvastatin calcium | ROSUVASTATIN CALCIUM | Preferred Pharmaceuticals Inc. | 662c6f1a-ca1e-40ea-952d-122b680fdb89 | 2025-01-09 | Warnings, Adverse reactions | 206434 ANDA206434 |
| Rosuvastatin | ROSUVASTATIN | Bryant Ranch Prepack | 0ad5b7de-e97d-4989-91e4-edae73543896 | 2024-10-30 | Warnings, Adverse reactions | 206434 ANDA206434 |
| Rosuvastatin | ROSUVASTATIN | Bryant Ranch Prepack | aa7443b0-9f75-47fc-a5ce-c7245444419c | 2024-10-30 | Warnings, Adverse reactions | 206434 ANDA206434 |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | Proficient Rx LP | eaf91ddd-0d4f-4c77-9dba-a2a3abb86ea4 | 2022-11-01 | Warnings, Adverse reactions | 206434 ANDA206434 |
| Rosuvastatin calcium | ROSUVASTATIN CALCIUM | Proficient Rx LP | aa64d28f-0926-4ff2-bb28-578e5ef233eb | 2022-11-01 | Warnings, Adverse reactions | 206434 ANDA206434 |
| Rosuvastatin calcium | ROSUVASTATIN CALCIUM | Proficient Rx LP | a1b4d50b-eda3-437c-9c80-4d854361ddc2 | 2022-11-01 | Warnings, Adverse reactions | 206434 ANDA206434 |
| Rosuvastatin calcium | ROSUVASTATIN CALCIUM | Proficient Rx LP | 5a874865-3cbe-4589-9787-046feb9a2c46 | 2022-11-01 | Warnings, Adverse reactions | 206434 ANDA206434 |
| Rosuvastatin calcium | ROSUVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | a5ee9510-e691-49ec-a5cd-49e70371ee4d | 2019-01-09 | Warnings, Adverse reactions | 206434 ANDA206434 |
| Rosuvastatin calcium | ROSUVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | 410a0a03-6751-4c3d-82bf-c7c6a4081fdd | 2018-11-13 | Warnings, Adverse reactions | 206434 ANDA206434 |
| Rosuvastatin calcium | ROSUVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | 69dfa637-2a81-4c7e-8fef-d4b4ab4c3f25 | 2018-06-30 | Warnings, Adverse reactions | 206434 ANDA206434 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68788-7971-3 | 68788797103 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-7971-3) | 2021-07-21 | 0000-00-00 | No | No | Current |
| 68788-7971-6 | 68788797106 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-7971-6) | 2021-07-21 | 0000-00-00 | No | No | Current |
| 68788-7971-9 | 68788797109 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-7971-9) | 2021-07-21 | 0000-00-00 | No | No | Current |