Prednisone
- Product NDC
- 50090-4428
- 11-digit product format
- 500904428
- Labeler code
- 50090
- Product ID
- 50090-4428_d05eef24-e5ea-4d58-b083-1701d2b53d72
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Prednisone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA040362
- Marketing category
- ANDA
- Marketing start
- 2001-08-29
- Marketing end
- 0000-00-00
- Substance
- PREDNISONE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 | 50090-4428 | I | Inactivated by FDA | 2026-08-03 | ||
| excluded package | package | 50090-4428 | 50090-4428-0 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 50090-4428 | 50090-4428-1 | I | Inactivated by FDA | 2026-08-03 |
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 | 50090-4428-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-4428-0 | 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 | 50090-4428-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-4428-0 | 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 | 50090-4428-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 50090-4428-0 | 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 | 50090-4428-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 50090-4428-0 | 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 | 50090-4428-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 50090-4428-0 | 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 | 50090-4428-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 50090-4428-0 | 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 | 50090-4428-1 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50090-4428-0 | 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 | 50090-4428-1 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50090-4428-0 | 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 | 50090-4428-1 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50090-4428-0 | 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 | 50090-4428-1 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 50090-4428-0 | 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 | 50090-4428-1 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 50090-4428-0 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 50090-4428-1 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 50090-4428-0 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 50090-4428-1 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 50090-4428-0 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 50090-4428-1 | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 50090-4428-0 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 50090-4428-1 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 50090-4428-0 | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040362-001 | PREDNISONE | PREDNISONE | 10MG | TABLET / ORAL | AB | 2001-08-29 | |
| A040362-002 | PREDNISONE | PREDNISONE | 5MG | TABLET / ORAL | AB | 2001-08-29 | |
| A040362-003 | PREDNISONE | PREDNISONE | 20MG | TABLET / ORAL | AB | 2005-06-29 | |
| A040362-004 | PREDNISONE | PREDNISONE | 2.5MG | TABLET / ORAL | AB | 2023-04-17 | |
| A040362-005 | PREDNISONE | PREDNISONE | 50MG | TABLET / ORAL | AB | 2023-04-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040362-001 | AB |
| A040362-002 | AB |
| A040362-003 | AB |
| A040362-004 | AB |
| A040362-005 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A040362-001 | PREDNISONE | 10MG | TABLET / ORAL | AB | 2001-08-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040362-002 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2001-08-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040362-003 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2005-06-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040362-004 | PREDNISONE | 2.5MG | TABLET / ORAL | AB | 2023-04-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040362-005 | PREDNISONE | 50MG | TABLET / ORAL | AB | 2023-04-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040362-001 | PREDNISONE | 10MG | TABLET / ORAL | AB | 2001-08-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040362-002 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2001-08-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040362-003 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2005-06-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040362-004 | PREDNISONE | 2.5MG | TABLET / ORAL | AB | 2023-04-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040362-005 | PREDNISONE | 50MG | TABLET / ORAL | AB | 2023-04-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040362-001 | PREDNISONE | 10MG | TABLET / ORAL | AB | 2001-08-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040362-002 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2001-08-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040362-003 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2005-06-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040362-004 | PREDNISONE | 2.5MG | TABLET / ORAL | AB | 2023-04-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040362-005 | PREDNISONE | 50MG | TABLET / ORAL | AB | 2023-04-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040362-001 | PREDNISONE | 10MG | TABLET / ORAL | AB | 2001-08-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040362-002 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2001-08-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040362-003 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2005-06-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040362-004 | PREDNISONE | 2.5MG | TABLET / ORAL | AB | 2023-04-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040362-005 | PREDNISONE | 50MG | TABLET / ORAL | AB | 2023-04-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040362-001 | PREDNISONE | 10MG | TABLET / ORAL | AB | 2001-08-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040362-002 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2001-08-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040362-003 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2005-06-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040362-004 | PREDNISONE | 2.5MG | TABLET / ORAL | AB | 2023-04-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040362-005 | PREDNISONE | 50MG | TABLET / ORAL | AB | 2023-04-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040362-001 | PREDNISONE | 10MG | TABLET / ORAL | AB | 2001-08-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040362-002 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2001-08-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040362-003 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2005-06-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040362-004 | PREDNISONE | 2.5MG | TABLET / ORAL | AB | 2023-04-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040362-005 | PREDNISONE | 50MG | TABLET / ORAL | AB | 2023-04-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040362-001 | PREDNISONE | 10MG | TABLET / ORAL | AB | 2001-08-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040362-002 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2001-08-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040362-003 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2005-06-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040362-004 | PREDNISONE | 2.5MG | TABLET / ORAL | AB | 2023-04-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040362-005 | PREDNISONE | 50MG | TABLET / ORAL | AB | 2023-04-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040362-001 | PREDNISONE | 10MG | TABLET / ORAL | AB | 2001-08-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040362-002 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2001-08-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040362-003 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2005-06-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040362-004 | PREDNISONE | 2.5MG | TABLET / ORAL | AB | 2023-04-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040362-005 | PREDNISONE | 50MG | TABLET / ORAL | AB | 2023-04-17 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A040362-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040362-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040362-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040362-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040362-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040362-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040362-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040362-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040362-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040362-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040362-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040362-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040362-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040362-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040362-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040362-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040362-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040362-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040362-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040362-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040362-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040362-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040362-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040362-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040362-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040362-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040362-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040362-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040362-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040362-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040362-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040362-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040362-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040362-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040362-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040362-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040362-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040362-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040362-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040362-005 | AB | 1 | 5bbf6a4d5a75… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 2205d503-be51-445b-bb34-c209cc557b3c | Product name | 5 | 20230105 |
| 9492a99d-61c8-491f-9086-1c6a7e98c040 | Product name | 6 | 20230105 |
| 205c2cdd-a63b-cbc9-6bcb-6be6001edf81 | Product name | 2 | 20170705 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-4428-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-c44d-0266-e053-dadaa90a7c1a | PredniSONE Tablets, USP Rx only |
| 50090-4428-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-c44d-0266-e053-dadaa90a7c1a | PredniSONE Tablets, USP Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-4428-0 | Prednisone | 15 in 1 BOTTLE | TABLET | 15 | 1 | |
| 50090-4428-1 | Prednisone | 15 in 1 BOTTLE | TABLET | 15 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-4428 | PREDNISONE (PREDNISONE) TABLET [A-S MEDICATION SOLUTIONS] | 1 | Legacy NDC, 2 package rows | 20200822_3f4f6272-e051-41f0-a1a1-7abfcc3aa884.zip |
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 |
|---|---|---|---|---|---|---|
| Prednisone | PREDNISONE | A-S Medication Solutions | 74102cc5-7a1a-4a0f-a07f-a4b0f86bcabf | 2025-07-23 | Warnings, Adverse reactions | 040362 ANDA040362 |
| Prednisone | PREDNISONE | A-S Medication Solutions | dc94273f-af06-4bd5-9ce3-ce0a0f36587b | 2025-07-03 | Warnings, Adverse reactions | 040362 ANDA040362 |
| Prednisone | PREDNISONE | Advanced Rx of Tennessee, LLC | af863b9e-964b-3b1e-e053-2995a90ab93a | 2024-12-31 | Warnings, Adverse reactions | 040362 ANDA040362 |
| Prednisone | PREDNISONE | Advanced Rx Pharmacy of Tennessee, LLC | b3dbf833-b929-8c85-e053-2995a90a5896 | 2024-12-31 | Warnings, Adverse reactions | 040362 ANDA040362 |
| Prednisone | PREDNISONE | Advanced Rx Pharmacy of Tennessee, LLC | e1e7d14b-80b2-f57e-e053-2995a90af112 | 2024-12-31 | Warnings, Adverse reactions | 040362 ANDA040362 |
| Prednisone | PREDNISONE | Advanced Rx Pharmacy of Tennessee, LLC | b3dbff9f-610f-7782-e053-2a95a90a71c1 | 2024-12-31 | Warnings, Adverse reactions | 040362 ANDA040362 |
| Prednisone | PREDNISONE | NuCare Pharmaceuticals,Inc. | 62fdf3c2-cfa9-d573-e053-2a91aa0a833b | 2024-08-14 | Warnings, Adverse reactions | 040362 ANDA040362 |
| Prednisone | PREDNISONE | NuCare Pharmaceuticals,Inc. | 62ec965c-e682-9920-e053-2a91aa0adcdb | 2024-08-14 | Warnings, Adverse reactions | 040362 ANDA040362 |
| Prednisone | PREDNISONE | NuCare Pharmaceuticals,Inc. | 62ff1da3-79aa-676a-e053-2991aa0a4a9f | 2024-07-19 | Warnings, Adverse reactions | 040362 ANDA040362 |
| Prednisone | PREDNISONE | A-S Medication Solutions | 751b7f62-f92b-4b7c-a588-2c882d5d1ce3 | 2024-06-25 | Warnings, Adverse reactions | 040362 ANDA040362 |
| Prednisone | PREDNISONE | A-S Medication Solutions | cb1b0dc0-6916-4e6f-9775-26ea0f593f83 | 2024-06-03 | Warnings, Adverse reactions | 040362 ANDA040362 |
| Prednisone | PREDNISONE | NuCare Pharmaceuticals,Inc. | 63106192-35d5-6989-e053-2991aa0aa714 | 2024-04-25 | Warnings, Adverse reactions | 040362 ANDA040362 |
| Prednisone | PREDNISONE | A-S Medication Solutions | 5c8ffc9d-3804-40d3-ae2c-1fbac7bdc8d2 | 2024-04-02 | Warnings, Adverse reactions | 040362 ANDA040362 |
| Prednisone | PREDNISONE | NuCare Pharmaceuticals,Inc. | 63102d75-9b2b-84a9-e053-2a91aa0a317d | 2024-02-09 | Warnings, Adverse reactions | 040362 ANDA040362 |
| Prednisone | PREDNISONE | Proficient Rx LP | 5961b1d4-6a4c-452f-b3f1-c99f3a9a6445 | 2023-09-01 | Warnings, Adverse reactions | 040362 ANDA040362 |
| Prednisone | PREDNISONE | Asclemed USA, Inc. | dc663fd3-b149-48ae-a3f3-6abaa4808cc6 | 2020-08-28 | Warnings, Adverse reactions | 040362 ANDA040362 |
| Prednisone | PREDNISONE | Proficient Rx LP | e4555299-af68-416f-8999-9bb703a45e77 | 2019-10-01 | Warnings, Adverse reactions | 040362 ANDA040362 |
| Prednisone | PREDNISONE | Proficient Rx LP | 7c650dc8-43f6-4257-81ed-c93b00202d06 | 2019-10-01 | Warnings, Adverse reactions | 040362 ANDA040362 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312615 | predniSONE 20 MG Oral Tablet | PSN | 3f4f6272-e051-41f0-a1a1-7abfcc3aa884 | 1 |
| 312615 | prednisone 20 MG Oral Tablet | SCD | 3f4f6272-e051-41f0-a1a1-7abfcc3aa884 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-4428-0 | 50090442800 | 15 TABLET in 1 BOTTLE (50090-4428-0) | 15 tablet | 2019-07-19 | 0000-00-00 | No | No | Current |
| 50090-4428-1 | 50090442801 | 15 TABLET in 1 BOTTLE (50090-4428-1) | 15 tablet | 2019-07-19 | 0000-00-00 | No | No | Current |