PREDNISONE
- Product NDC
- 61919-235
- Requested package NDC
- 61919-235-42
- 11-digit product format
- 619190235
- Labeler code
- 61919
- Product ID
- 61919-235_e9ac6406-d20e-e936-e053-2a95a90a0075
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PREDNISONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA040362
- Marketing category
- ANDA
- Marketing start
- 2019-08-29
- Marketing end
- 0000-00-00
- Substance
- PREDNISONE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- 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 | 61919-235 | 61919-235-42 | 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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
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 | Indexing SPL | Related label |
|---|---|---|---|
| 61919-235-10 | 2025-01-30 | 2cef2736-9b96-d83d-e063-dadaa90ab31f | PREDNISONE |
| 61919-235-15 | 2025-01-30 | 2cef2736-61a7-d83d-e063-dadaa90ab31f | PREDNISONE |
| 61919-235-21 | 2025-01-30 | 9d75b9d1-11dc-f424-e053-dadaa90a57ce | PREDNISONE |
| 61919-235-30 | 2025-01-30 | 9d75b9d1-11dc-f424-e053-dadaa90a57ce | PREDNISONE |
| 61919-235-40 | 2025-01-30 | 2cef2736-61a7-d83d-e063-dadaa90ab31f | PREDNISONE |
| 61919-235-42 | 2025-01-30 | 2cef2736-7b21-d83d-e063-dadaa90ab31f | PREDNISONE |
| 61919-235-21 | 2021-01-07 | 9d75b9d1-11dc-f424-e053-dadaa90a57ce | PREDNISONE |
| 61919-235-30 | 2021-01-07 | 9d75b9d1-11dc-f424-e053-dadaa90a57ce | PREDNISONE |
| 61919-235-21 | 2020-01-31 | 9d75b9d1-11dc-f424-e053-dadaa90a57ce | PREDNISONE |
| 61919-235-30 | 2020-01-31 | 9d75b9d1-11dc-f424-e053-dadaa90a57ce | PREDNISONE |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61919-235-21 | PREDNISONE | 21 in 1 BOTTLE | TABLET | 21 | 8 | |
| 61919-235-30 | PREDNISONE | 30 in 1 BOTTLE | TABLET | 30 | 8 | |
| 61919-235-15 | PREDNISONE | 15 in 1 BOTTLE | TABLET | 15 | 7 | |
| 61919-235-40 | PREDNISONE | 40 in 1 BOTTLE | TABLET | 40 | 7 | |
| 61919-235-10 | PREDNISONE | 10 in 1 BOTTLE | TABLET | 10 | 2 | |
| 61919-235-42 | PREDNISONE | 42 in 1 BOTTLE | TABLET | 42 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61919-235-10 | EA - Each | 61919-235 | 1620380b-e285-487b-aeb4-b5bdb74371be | 1 | 2019-09-05 |
| 61919-235-15 | EA - Each | 61919-235 | 4b48fac2-83e7-48c5-9c75-45e1bd317924 | 1 | 2020-07-13 |
| 61919-235-21 | EA - Each | 61919-235 | 1cc858e1-f9ae-4cae-8a4c-5790b5151355 | 1 | 2016-12-07 |
| 61919-235-30 | EA - Each | 61919-235 | ab660997-0eee-495f-bb44-65ef742dd03f | 1 | 2015-10-02 |
| 61919-235-40 | EA - Each | 61919-235 | 66ec607c-1506-4f87-8e48-2250e34aeb0e | 1 | 2019-09-05 |
| 61919-235-42 | EA - Each | 61919-235 | a07daec6-6afd-46b5-a851-79c322bf874f | 1 | 2019-09-05 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Prednisone | ACTIVE INGREDIENT | VB0R961HZT | PREDNISONE TABLET [DIRECT RX] | 1 | |
| PREDNISONE | ACTIVE MOIETY | VB0R961HZT | PREDNISONE TABLET [DIRECT RX] | 1 | |
| Lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | PREDNISONE TABLET [DIRECT RX] | 1 | |
| Magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | PREDNISONE TABLET [DIRECT RX] | 1 | |
| Sodium lauryl sulfate | INACTIVE INGREDIENT | 368GB5141J | PREDNISONE TABLET [DIRECT RX] | 1 | |
| Starch, Corn | INACTIVE INGREDIENT | O8232NY3SJ | PREDNISONE TABLET [DIRECT RX] | 1 | |
| Starch, Potato | INACTIVE INGREDIENT | 8I089SAH3T | PREDNISONE TABLET [DIRECT RX] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61919-235 | PREDNISONE TABLET [DIRECT RX] | 8 | Legacy NDC, 2 package rows | 20210108_bd4ad91b-c497-4961-8f33-1bdaf2979b7a.zip |
| 61919-235 | PREDNISONE TABLET [DIRECT_RX] | 7 | Legacy NDC, 2 package rows | 20230415_91419b52-854a-6670-e053-2a95a90aec24.zip |
| 61919-235 | PREDNISONE TABLET [DIRECT_RX] | 2 | Legacy NDC, 1 package rows | 20210108_8f8c1961-0bdb-2d8a-e053-2a95a90a5fe7.zip |
| 61919-235 | PREDNISONE TABLET [DIRECT_RX] | 2 | Legacy NDC, 1 package rows | 20210108_8f8c295f-b6ee-6c6f-e053-2995a90aad9e.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 |
|---|---|---|---|---|
| 198145 | predniSONE 10 MG Oral Tablet | PSN | bd4ad91b-c497-4961-8f33-1bdaf2979b7a | 8 |
| 198145 | prednisone 10 MG Oral Tablet | SCD | bd4ad91b-c497-4961-8f33-1bdaf2979b7a | 8 |
| 198145 | predniSONE 10 MG Oral Tablet | PSN | 91419b52-854a-6670-e053-2a95a90aec24 | 7 |
| 198145 | prednisone 10 MG Oral Tablet | SCD | 91419b52-854a-6670-e053-2a95a90aec24 | 7 |
| 198145 | predniSONE 10 MG Oral Tablet | PSN | 8f8c1961-0bdb-2d8a-e053-2a95a90a5fe7 | 2 |
| 198145 | predniSONE 10 MG Oral Tablet | PSN | 8f8c295f-b6ee-6c6f-e053-2995a90aad9e | 2 |
| 198145 | prednisone 10 MG Oral Tablet | SCD | 8f8c1961-0bdb-2d8a-e053-2a95a90a5fe7 | 2 |
| 198145 | prednisone 10 MG Oral Tablet | SCD | 8f8c295f-b6ee-6c6f-e053-2995a90aad9e | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61919-235-42 | 61919023542 | 42 TABLET in 1 BOTTLE (61919-235-42) | 42 tablet | 2019-08-07 | 0000-00-00 | No | No | Current |