PredniSONE Tablets, USP, 5 mg
- Product NDC
- 72789-474
- Requested package NDC
- 72789-474-04
- 11-digit product format
- 727890474
- Labeler code
- 72789
- Product ID
- 72789-474_4ddfaff7-3273-e76e-e063-6294a90a01c9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PredniSONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA212629
- Marketing category
- ANDA
- Marketing start
- 2025-05-22
- Substance
- PREDNISONE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A212629-001 | PREDNISONE | PREDNISONE | 5MG | TABLET / ORAL | AB | 2023-12-05 | |
| A212629-002 | PREDNISONE | PREDNISONE | 10MG | TABLET / ORAL | AB | 2023-12-05 | |
| A212629-003 | PREDNISONE | PREDNISONE | 20MG | TABLET / ORAL | AB | 2023-12-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A212629-001 | AB |
| A212629-002 | AB |
| A212629-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A212629-001 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2023-12-05 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A212629-002 | PREDNISONE | 10MG | TABLET / ORAL | AB | 2023-12-05 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A212629-003 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2023-12-05 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A212629-001 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2023-12-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A212629-002 | PREDNISONE | 10MG | TABLET / ORAL | AB | 2023-12-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A212629-003 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2023-12-05 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212629-001 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2023-12-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212629-002 | PREDNISONE | 10MG | TABLET / ORAL | AB | 2023-12-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212629-003 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2023-12-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212629-001 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2023-12-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212629-002 | PREDNISONE | 10MG | TABLET / ORAL | AB | 2023-12-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212629-003 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2023-12-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212629-001 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2023-12-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212629-002 | PREDNISONE | 10MG | TABLET / ORAL | AB | 2023-12-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212629-003 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2023-12-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212629-001 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2023-12-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212629-002 | PREDNISONE | 10MG | TABLET / ORAL | AB | 2023-12-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212629-003 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2023-12-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212629-001 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2023-12-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212629-002 | PREDNISONE | 10MG | TABLET / ORAL | AB | 2023-12-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212629-003 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2023-12-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212629-001 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2023-12-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212629-002 | PREDNISONE | 10MG | TABLET / ORAL | AB | 2023-12-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212629-003 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2023-12-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212629-001 | PREDNISONE | 5MG | TABLET / ORAL | 2023-12-05 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212629-002 | PREDNISONE | 10MG | TABLET / ORAL | 2023-12-05 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212629-003 | PREDNISONE | 20MG | TABLET / ORAL | 2023-12-05 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212629-001 | PREDNISONE | 5MG | TABLET / ORAL | 2023-12-05 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212629-002 | PREDNISONE | 10MG | TABLET / ORAL | 2023-12-05 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212629-003 | PREDNISONE | 20MG | TABLET / ORAL | 2023-12-05 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212629-001 | PREDNISONE | 5MG | TABLET / ORAL | 2023-12-05 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212629-002 | PREDNISONE | 10MG | TABLET / ORAL | 2023-12-05 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212629-003 | PREDNISONE | 20MG | TABLET / ORAL | 2023-12-05 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A212629-001 | PREDNISONE | 5MG | TABLET / ORAL | 2023-12-05 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A212629-002 | PREDNISONE | 10MG | TABLET / ORAL | 2023-12-05 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A212629-003 | PREDNISONE | 20MG | TABLET / ORAL | 2023-12-05 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212629-001 | PREDNISONE | 5MG | TABLET / ORAL | 2023-12-05 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212629-002 | PREDNISONE | 10MG | TABLET / ORAL | 2023-12-05 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212629-003 | PREDNISONE | 20MG | TABLET / ORAL | 2023-12-05 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212629-001 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2023-12-05 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A212629-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A212629-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A212629-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A212629-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A212629-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A212629-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A212629-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212629-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212629-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212629-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212629-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212629-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A212629-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212629-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212629-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212629-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212629-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212629-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212629-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212629-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212629-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212629-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212629-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212629-003 | AB | 1 | 03ed91905a0d… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212629-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212629-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212629-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212629-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212629-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212629-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A212629-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A212629-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A212629-003 | AB | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A212629-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A212629-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A212629-003 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A212629-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A212629-002 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A212629-003 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A212629-001 | AB | 1 | ea1830bbd6c7… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PredniSONE Tablets, USP, 5 mg
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PREDNISONE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| VB0R961HZT | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 312617 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| d6df3295-3118-49af-be05-b1fab0d4adaa | 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72789-474-01 | PredniSONE Tablets, USP, 5 mg | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | 8 | |
| 72789-474-04 | PredniSONE Tablets, USP, 5 mg | 4 in 1 BOTTLE, PLASTIC | TABLET | 4 | 8 | |
| 72789-474-21 | PredniSONE Tablets, USP, 5 mg | 21 in 1 BOTTLE, PLASTIC | TABLET | 21 | 8 | |
| 72789-474-95 | PredniSONE Tablets, USP, 5 mg | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72789-474-01 | EA - Each | 72789-474 | 05788a5a-febb-4e16-b509-1132b0b0f0b0 | 1 | 2025-05-14 |
| 72789-474-04 | EA - Each | 72789-474 | 7b0878e5-4522-4ff3-841e-8aa65de9747e | 1 | 2026-01-08 |
| 72789-474-21 | EA - Each | 72789-474 | 7259863f-7ada-4612-9693-e724b93b1273 | 1 | 2025-10-14 |
| 72789-474-95 | EA - Each | 72789-474 | d5b41f51-f422-4470-973a-8528d86f35ce | 1 | 2025-05-14 |
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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312617 | predniSONE 5 MG Oral Tablet | PSN | d6df3295-3118-49af-be05-b1fab0d4adaa | 8 |
| 312617 | prednisone 5 MG Oral Tablet | SCD | d6df3295-3118-49af-be05-b1fab0d4adaa | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 72789-474-04 | 72789047404 | 4 TABLET in 1 BOTTLE, PLASTIC (72789-474-04) | 4 tablet | 2025-12-24 | No | No | Current |