Prednisone
- Product NDC
- 0603-5339
- 11-digit product format
- 006035339
- Labeler code
- 0603
- Product ID
- 0603-5339_e6628b5c-a3e4-462b-a01a-695ed8d3ab64
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Prednisone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Endo USA, Inc.
- Application
- ANDA040392
- Marketing category
- ANDA
- Marketing start
- 2003-02-12
- Substance
- PREDNISONE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040392-001 | PREDNISONE | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040392-001 | 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 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A040392-001 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2003-02-12 | e64feba35796… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A040392-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A040392-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040392-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040392-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040392-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040392-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040392-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040392-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040392-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040392-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040392-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040392-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040392-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040392-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040392-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040392-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A040392-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A040392-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A040392-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A040392-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A040392-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040392-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A040392-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A040392-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A040392-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A040392-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A040392-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A040392-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A040392-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A040392-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A040392-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040392-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040392-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040392-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040392-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A040392-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A040392-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040392-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A040392-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A040392-001 | AB | 1 | e64feba35796… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Prednisone
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PREDNISONE | 20 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| VB0R961HZT | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 198144 | Internal RxNorm lookup |
| 198145 | Internal RxNorm lookup |
| 198146 | Internal RxNorm lookup |
| 312615 | Internal RxNorm lookup |
| 312617 | Internal RxNorm lookup |
| 763179 | Internal RxNorm lookup |
| 763181 | Internal RxNorm lookup |
| 763183 | Internal RxNorm lookup |
| 763185 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 10fe5a3b-84dc-4600-87c2-b80c97ce18cf | Available on FDA.report |
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#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0603-5339-21 | Prednisone | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | 32 | |
| 0603-5339-28 | Prednisone | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | 32 | |
| 0603-5339-32 | Prednisone | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | 32 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0603-5339-21 | EA - Each | 0603-5339 | c755f277-69c7-4676-b2fe-2bc9cac41639 | 1 | 2012-07-24 |
| 0603-5339-28 | EA - Each | 0603-5339 | 83c832bf-3484-4d4d-9d5c-78ba2a65e8dc | 1 | 2012-07-24 |
| 0603-5339-32 | EA - Each | 0603-5339 | 10bb53a9-d767-485b-9ad8-1e2b44101e6d | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 | Par Health USA, LLC | 10fe5a3b-84dc-4600-87c2-b80c97ce18cf | 2026-07-31 | Warnings, Adverse reactions | 040392 ANDA040392 0603-5339 |
| Prednisone | PREDNISONE | Cardinal Health 107, LLC | 199ed6a6-d9d9-49de-b383-5933a026591b | 2026-01-27 | Warnings, Adverse reactions | 040392 ANDA040392 |
| Prednisone | PREDNISONE | American Health Packaging | a0e8d1a2-8c82-4dc0-8c2f-9da84382f34e | 2025-12-23 | Warnings, Adverse reactions | 040392 ANDA040392 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0603-5339-21 | 00603533921 | 100 TABLET in 1 BOTTLE, PLASTIC (0603-5339-21) | 100 tablet | 2003-02-12 | 0000-00-00 | No | No | Current |
| 0603-5339-28 | 00603533928 | 500 TABLET in 1 BOTTLE, PLASTIC (0603-5339-28) | 500 tablet | 2003-02-12 | 0000-00-00 | No | No | Current |
| 0603-5339-32 | 00603533932 | 1000 TABLET in 1 BOTTLE, PLASTIC (0603-5339-32) | 1000 tablet | 2003-02-12 | 0000-00-00 | No | No | Current |