Prednisone
- Product NDC
- 68071-3617
- 11-digit product format
- 680713617
- Labeler code
- 68071
- Product ID
- 68071-3617_266c8cce-cdc9-557d-e063-6394a90a9bc3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Prednisone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA211575
- Marketing category
- ANDA
- Marketing start
- 2019-11-15
- 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 |
|---|---|---|---|---|---|---|---|
| A211575-001 | PREDNISONE | PREDNISONE | 2.5MG | TABLET / ORAL | AB | 2019-11-15 | |
| A211575-002 | PREDNISONE | PREDNISONE | 5MG | TABLET / ORAL | AB | 2019-11-15 | |
| A211575-003 | PREDNISONE | PREDNISONE | 10MG | TABLET / ORAL | AB | 2019-11-15 | |
| A211575-004 | PREDNISONE | PREDNISONE | 20MG | TABLET / ORAL | AB | 2019-11-15 | |
| A211575-005 | PREDNISONE | PREDNISONE | 50MG | TABLET / ORAL | AB | 2019-11-15 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A211575-001 | AB |
| A211575-002 | AB |
| A211575-003 | AB |
| A211575-004 | AB |
| A211575-005 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A211575-001 | PREDNISONE | 2.5MG | TABLET / ORAL | AB | 2019-11-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A211575-002 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2019-11-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A211575-003 | PREDNISONE | 10MG | TABLET / ORAL | AB | 2019-11-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A211575-004 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2019-11-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A211575-005 | PREDNISONE | 50MG | TABLET / ORAL | AB | 2019-11-15 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A211575-001 | PREDNISONE | 2.5MG | TABLET / ORAL | AB | 2019-11-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211575-002 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2019-11-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211575-003 | PREDNISONE | 10MG | TABLET / ORAL | AB | 2019-11-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211575-004 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2019-11-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211575-005 | PREDNISONE | 50MG | TABLET / ORAL | AB | 2019-11-15 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211575-001 | PREDNISONE | 2.5MG | TABLET / ORAL | AB | 2019-11-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211575-002 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2019-11-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211575-003 | PREDNISONE | 10MG | TABLET / ORAL | AB | 2019-11-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211575-004 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2019-11-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211575-005 | PREDNISONE | 50MG | TABLET / ORAL | AB | 2019-11-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211575-001 | PREDNISONE | 2.5MG | TABLET / ORAL | AB | 2019-11-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211575-002 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2019-11-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211575-003 | PREDNISONE | 10MG | TABLET / ORAL | AB | 2019-11-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211575-004 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2019-11-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211575-005 | PREDNISONE | 50MG | TABLET / ORAL | AB | 2019-11-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211575-001 | PREDNISONE | 2.5MG | TABLET / ORAL | AB | 2019-11-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211575-002 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2019-11-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211575-003 | PREDNISONE | 10MG | TABLET / ORAL | AB | 2019-11-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211575-004 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2019-11-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211575-005 | PREDNISONE | 50MG | TABLET / ORAL | AB | 2019-11-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211575-001 | PREDNISONE | 2.5MG | TABLET / ORAL | AB | 2019-11-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211575-002 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2019-11-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211575-003 | PREDNISONE | 10MG | TABLET / ORAL | AB | 2019-11-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211575-004 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2019-11-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211575-005 | PREDNISONE | 50MG | TABLET / ORAL | AB | 2019-11-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211575-001 | PREDNISONE | 2.5MG | TABLET / ORAL | AB | 2019-11-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211575-002 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2019-11-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211575-003 | PREDNISONE | 10MG | TABLET / ORAL | AB | 2019-11-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211575-004 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2019-11-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211575-005 | PREDNISONE | 50MG | TABLET / ORAL | AB | 2019-11-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211575-001 | PREDNISONE | 2.5MG | TABLET / ORAL | AB | 2019-11-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211575-002 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2019-11-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211575-003 | PREDNISONE | 10MG | TABLET / ORAL | AB | 2019-11-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211575-004 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2019-11-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211575-005 | PREDNISONE | 50MG | TABLET / ORAL | AB | 2019-11-15 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A211575-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211575-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211575-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211575-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211575-005 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A211575-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211575-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211575-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211575-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211575-005 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A211575-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211575-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211575-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211575-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211575-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211575-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211575-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211575-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211575-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211575-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A211575-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211575-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211575-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211575-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211575-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211575-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211575-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211575-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211575-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211575-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211575-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211575-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211575-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211575-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211575-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211575-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211575-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211575-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211575-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211575-005 | AB | 1 | 03ed91905a0d… |
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
- Listing expiration
- 2026-12-31
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 |
|---|---|
| 312615 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1b42449a-2be8-e4fb-e063-6394a90aff98 | 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 |
|---|---|---|---|---|---|---|
| 68071-3617-1 | Prednisone | 10 in 1 BOTTLE | TABLET | 10 | 5 | |
| 68071-3617-4 | Prednisone | 14 in 1 BOTTLE | TABLET | 14 | 5 | |
| 68071-3617-6 | Prednisone | 60 in 1 BOTTLE | TABLET | 60 | 5 | |
| 68071-3617-7 | Prednisone | 21 in 1 BOTTLE | TABLET | 21 | 5 | |
| 68071-3617-8 | Prednisone | 8 in 1 BOTTLE | TABLET | 8 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-3617 | PREDNISONE TABLET [NUCARE PHARMACEUTICALS,INC.] | 5 | Current NDC, 5 package rows | 20241109_1b42449a-2be8-e4fb-e063-6394a90aff98.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 | Bryant Ranch Prepack | c60a07f9-ed9f-4434-a69d-2e2fea4843fd | 2026-08-20 | Warnings, Adverse reactions | 211575 ANDA211575 |
| Prednisone | PREDNISONE | Bryant Ranch Prepack | 7ea7f6a9-78ef-42fe-baac-f817da3976fb | 2026-08-20 | Warnings, Adverse reactions | 211575 ANDA211575 |
| Prednisone | PREDNISONE | PD-Rx Pharmaceuticals, Inc. | 19fdbf9f-3a64-b9fa-e063-6394a90af086 | 2026-07-29 | Warnings, Adverse reactions | 211575 ANDA211575 |
| Prednisone | PREDNISONE | PD-Rx Pharmaceuticals, Inc. | 1a9f00ac-ec92-4d2c-e063-6394a90ac4f6 | 2026-07-29 | Warnings, Adverse reactions | 211575 ANDA211575 |
| Prednisone | PREDNISONE | PD-Rx Pharmaceuticals, Inc. | 25b5958b-c151-9200-e063-6394a90af52c | 2026-07-29 | Warnings, Adverse reactions | 211575 ANDA211575 |
| Prednisone | PREDNISONE | PD-Rx Pharmaceuticals, Inc. | 1349a022-639b-4494-99a2-1594c7c0f0e9 | 2026-07-21 | Warnings, Adverse reactions | 211575 ANDA211575 |
| Prednisone | PREDNISONE | ANI Pharmaceuticals, Inc. | f05eb734-07e7-491c-b2e9-aae340e03750 | 2026-07-10 | Warnings, Adverse reactions | 211575 ANDA211575 |
| Prednisone | PREDNISONE | St. Mary's Medical Park Pharmacy | 1b3ea4cc-5bc6-ae47-e063-6294a90af13d | 2026-06-15 | Warnings, Adverse reactions | 211575 ANDA211575 |
| Prednisone | PREDNISONE | Aphena Pharma Solutions - Tennessee, LLC | 18818282-68aa-82e9-e063-6394a90aef54 | 2026-05-01 | Warnings, Adverse reactions | 211575 ANDA211575 |
| Prednisone D/P | PREDNISONE D/P | Direct_Rx | 4f0a3946-025c-798a-e063-6294a90a831b | 2026-04-09 | Warnings, Adverse reactions | 211575 ANDA211575 |
| Prednisone | PREDNISONE | Northwind Health Company, LLC | fbd3f0c3-06b3-c9b4-e053-6294a90a6fdd | 2026-04-07 | Warnings, Adverse reactions | 211575 ANDA211575 |
| Prednisone | PREDNISONE | Marlex Pharmaceuticals, Inc. | f499197b-b9b7-1707-e053-2a95a90a0932 | 2025-11-21 | Warnings, Adverse reactions | 211575 ANDA211575 |
| Prednisone | PREDNISONE | Proficient Rx LP | 08973b30-8576-4d31-aeef-934b72124e1f | 2025-05-01 | Warnings, Adverse reactions | 211575 ANDA211575 |
| Prednisone | PREDNISONE | Advanced Rx of Tennessee, LLC | 30956dd5-fe19-d5a9-e063-6394a90a2549 | 2025-04-04 | Warnings, Adverse reactions | 211575 ANDA211575 |
| Prednisone | PREDNISONE | NuCare Pharmaceuticals, Inc. | 31cfc21f-726b-ae80-e063-6294a90a9af4 | 2025-04-02 | Warnings, Adverse reactions | 211575 ANDA211575 |
| Prednisone | PREDNISONE | NuCare Pharmaceuticals,Inc. | 1b42449a-2be8-e4fb-e063-6394a90aff98 | 2024-11-08 | Warnings, Adverse reactions | 211575 ANDA211575 68071-3617 |
| Prednisone | PREDNISONE | NuCare Pharmaceuticals,Inc. | 1c33879e-8b2b-5843-e063-6294a90adea4 | 2024-07-01 | Warnings, Adverse reactions | 211575 ANDA211575 |
| Prednisone | PREDNISONE | A-S Medication Solutions | 8f7a38c7-7bf9-4951-b529-947cc9a57d6a | 2024-06-03 | Warnings, Adverse reactions | 211575 ANDA211575 |
| Prednisone | PREDNISONE | Proficient Rx LP | 71d70ec6-859a-4951-af98-248a864e1135 | 2022-09-01 | Warnings, Adverse reactions | 211575 ANDA211575 |
| Prednisone | PREDNISONE | Proficient Rx LP | 67681e4e-3002-4428-af5e-6ff1a950b037 | 2022-05-02 | Warnings, Adverse reactions | 211575 ANDA211575 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312615 | predniSONE 20 MG Oral Tablet | PSN | 1b42449a-2be8-e4fb-e063-6394a90aff98 | 5 |
| 312615 | prednisone 20 MG Oral Tablet | SCD | 1b42449a-2be8-e4fb-e063-6394a90aff98 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68071-3617-1 | 68071361701 | 10 TABLET in 1 BOTTLE (68071-3617-1) | 10 tablet | 2024-06-19 | No | No | Current |
| 68071-3617-4 | 68071361704 | 14 TABLET in 1 BOTTLE (68071-3617-4) | 14 tablet | 2024-06-19 | No | No | Current |
| 68071-3617-6 | 68071361706 | 60 TABLET in 1 BOTTLE (68071-3617-6) | 60 tablet | 2024-11-08 | No | No | Current |
| 68071-3617-7 | 68071361707 | 21 TABLET in 1 BOTTLE (68071-3617-7) | 21 tablet | 2024-10-16 | No | No | Current |
| 68071-3617-8 | 68071361708 | 8 TABLET in 1 BOTTLE (68071-3617-8) | 8 tablet | 2024-06-19 | No | No | Current |