Prednisone
- Product NDC
- 70518-3142
- Requested package NDC
- 70518-3142-2
- 11-digit product format
- 705183142
- Labeler code
- 70518
- Product ID
- 70518-3142_d2cc6d86-7c06-5ec1-e053-2995a90ae079
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Prednisone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA211575
- Marketing category
- ANDA
- Marketing start
- 2021-07-05
- Marketing end
- 0000-00-00
- Substance
- PREDNISONE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 | 70518-3142 | 70518-3142-2 | D | Discontinued by firm | 2026-08-17 |
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 | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70518-3142 | 70518-3142-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 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… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211575-001 | PREDNISONE | 2.5MG | TABLET / ORAL | AB | 2019-11-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211575-002 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2019-11-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211575-003 | PREDNISONE | 10MG | TABLET / ORAL | AB | 2019-11-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211575-004 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2019-11-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211575-005 | PREDNISONE | 50MG | TABLET / ORAL | AB | 2019-11-15 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 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… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211575-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211575-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211575-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211575-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211575-005 | AB | 1 | 2680178bc6a6… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 70518-3142-0 | 2023-03-17 | PredniSONE Tablets, USP 2.5mg, 5mg, 10mg, 20mg & 50mg Rx only |
| 70518-3142-1 | 2023-03-17 | PredniSONE Tablets, USP 2.5mg, 5mg, 10mg, 20mg & 50mg Rx only |
| 70518-3142-2 | 2023-03-17 | PredniSONE Tablets, USP 2.5mg, 5mg, 10mg, 20mg & 50mg Rx only |
| 70518-3142-0 | 2023-01-30 | PredniSONE Tablets, USP 2.5mg, 5mg, 10mg, 20mg & 50mg Rx only |
| 70518-3142-1 | 2023-01-30 | PredniSONE Tablets, USP 2.5mg, 5mg, 10mg, 20mg & 50mg Rx only |
| 70518-3142-2 | 2023-01-30 | PredniSONE Tablets, USP 2.5mg, 5mg, 10mg, 20mg & 50mg Rx only |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70518-3142 | PREDNISONE TABLET [REMEDYREPACK INC.] | 8 | Legacy NDC | 20240926_9e2bd1de-e759-46e0-a12f-734660e8e8bf.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 | 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 | Bryant Ranch Prepack | c60a07f9-ed9f-4434-a69d-2e2fea4843fd | 2025-03-31 | Warnings, Adverse reactions | 211575 ANDA211575 |
| Prednisone | PREDNISONE | Bryant Ranch Prepack | 7ea7f6a9-78ef-42fe-baac-f817da3976fb | 2025-03-31 | Warnings, Adverse reactions | 211575 ANDA211575 |
| Prednisone | PREDNISONE | NuCare Pharmaceuticals,Inc. | 1b42449a-2be8-e4fb-e063-6394a90aff98 | 2024-11-08 | Warnings, Adverse reactions | 211575 ANDA211575 |
| 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 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70518-3142-2 | 70518314202 | 180 TABLET in 1 BOTTLE, PLASTIC (70518-3142-2) | 180 tablet | 2021-12-09 | 0000-00-00 | No | No | Current |