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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212629-002 | PREDNISONE | 10MG | TABLET / ORAL | AB | 2023-12-05 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212629-003 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2023-12-05 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212629-001 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2023-12-05 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212629-002 | PREDNISONE | 10MG | TABLET / ORAL | AB | 2023-12-05 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212629-003 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2023-12-05 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A212629-001 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2023-12-05 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 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… |
| 2023-12-20 04:57 UTC | 2023-12 | A212629-002 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A212629-003 | AB | 1 | ea1830bbd6c7… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212629-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212629-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212629-003 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
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#
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 |