methylprednisolone
- Product NDC
- 70518-3622
- Requested package NDC
- 70518-3622-1
- 11-digit product format
- 705183622
- Labeler code
- 70518
- Product ID
- 70518-3622_5db7bfe0-d235-79ba-e063-6394a90ab4d4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- methylprednisolone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA206751
- Marketing category
- ANDA
- Marketing start
- 2023-01-25
- Substance
- METHYLPREDNISOLONE
- Active strength
- 4 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 |
|---|---|---|---|---|---|---|---|
| A206751-001 | METHYLPREDNISOLONE | METHYLPREDNISOLONE | 4MG | TABLET / ORAL | AB | 2018-04-23 | |
| A206751-002 | METHYLPREDNISOLONE | METHYLPREDNISOLONE | 8MG | TABLET / ORAL | AB | 2018-04-23 | |
| A206751-003 | METHYLPREDNISOLONE | METHYLPREDNISOLONE | 16MG | TABLET / ORAL | AB | 2018-04-23 | |
| A206751-004 | METHYLPREDNISOLONE | METHYLPREDNISOLONE | 32MG | TABLET / ORAL | AB | 2018-04-23 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A206751-001 | AB |
| A206751-002 | AB |
| A206751-003 | AB |
| A206751-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A206751-001 | METHYLPREDNISOLONE | 4MG | TABLET / ORAL | AB | 2018-04-23 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A206751-002 | METHYLPREDNISOLONE | 8MG | TABLET / ORAL | AB | 2018-04-23 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A206751-003 | METHYLPREDNISOLONE | 16MG | TABLET / ORAL | AB | 2018-04-23 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A206751-004 | METHYLPREDNISOLONE | 32MG | TABLET / ORAL | AB | 2018-04-23 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A206751-001 | METHYLPREDNISOLONE | 4MG | TABLET / ORAL | AB | 2018-04-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A206751-002 | METHYLPREDNISOLONE | 8MG | TABLET / ORAL | AB | 2018-04-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A206751-003 | METHYLPREDNISOLONE | 16MG | TABLET / ORAL | AB | 2018-04-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A206751-004 | METHYLPREDNISOLONE | 32MG | TABLET / ORAL | AB | 2018-04-23 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A206751-001 | METHYLPREDNISOLONE | 4MG | TABLET / ORAL | AB | 2018-04-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A206751-002 | METHYLPREDNISOLONE | 8MG | TABLET / ORAL | AB | 2018-04-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A206751-003 | METHYLPREDNISOLONE | 16MG | TABLET / ORAL | AB | 2018-04-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A206751-004 | METHYLPREDNISOLONE | 32MG | TABLET / ORAL | AB | 2018-04-23 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206751-001 | METHYLPREDNISOLONE | 4MG | TABLET / ORAL | AB | 2018-04-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206751-002 | METHYLPREDNISOLONE | 8MG | TABLET / ORAL | AB | 2018-04-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206751-003 | METHYLPREDNISOLONE | 16MG | TABLET / ORAL | AB | 2018-04-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206751-004 | METHYLPREDNISOLONE | 32MG | TABLET / ORAL | AB | 2018-04-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206751-001 | METHYLPREDNISOLONE | 4MG | TABLET / ORAL | AB | 2018-04-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206751-002 | METHYLPREDNISOLONE | 8MG | TABLET / ORAL | AB | 2018-04-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206751-003 | METHYLPREDNISOLONE | 16MG | TABLET / ORAL | AB | 2018-04-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206751-004 | METHYLPREDNISOLONE | 32MG | TABLET / ORAL | AB | 2018-04-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206751-001 | METHYLPREDNISOLONE | 4MG | TABLET / ORAL | AB | 2018-04-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206751-002 | METHYLPREDNISOLONE | 8MG | TABLET / ORAL | AB | 2018-04-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206751-003 | METHYLPREDNISOLONE | 16MG | TABLET / ORAL | AB | 2018-04-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206751-004 | METHYLPREDNISOLONE | 32MG | TABLET / ORAL | AB | 2018-04-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206751-001 | METHYLPREDNISOLONE | 4MG | TABLET / ORAL | AB | 2018-04-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206751-002 | METHYLPREDNISOLONE | 8MG | TABLET / ORAL | AB | 2018-04-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206751-003 | METHYLPREDNISOLONE | 16MG | TABLET / ORAL | AB | 2018-04-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206751-004 | METHYLPREDNISOLONE | 32MG | TABLET / ORAL | AB | 2018-04-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206751-001 | METHYLPREDNISOLONE | 4MG | TABLET / ORAL | AB | 2018-04-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206751-002 | METHYLPREDNISOLONE | 8MG | TABLET / ORAL | AB | 2018-04-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206751-003 | METHYLPREDNISOLONE | 16MG | TABLET / ORAL | AB | 2018-04-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206751-004 | METHYLPREDNISOLONE | 32MG | TABLET / ORAL | AB | 2018-04-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206751-001 | METHYLPREDNISOLONE | 4MG | TABLET / ORAL | AB | 2018-04-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206751-002 | METHYLPREDNISOLONE | 8MG | TABLET / ORAL | AB | 2018-04-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206751-003 | METHYLPREDNISOLONE | 16MG | TABLET / ORAL | AB | 2018-04-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206751-004 | METHYLPREDNISOLONE | 32MG | TABLET / ORAL | AB | 2018-04-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206751-001 | METHYLPREDNISOLONE | 4MG | TABLET / ORAL | AB | 2018-04-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206751-002 | METHYLPREDNISOLONE | 8MG | TABLET / ORAL | AB | 2018-04-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206751-003 | METHYLPREDNISOLONE | 16MG | TABLET / ORAL | AB | 2018-04-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206751-004 | METHYLPREDNISOLONE | 32MG | TABLET / ORAL | AB | 2018-04-23 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A206751-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A206751-002 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A206751-003 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A206751-004 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A206751-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A206751-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A206751-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A206751-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A206751-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A206751-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A206751-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A206751-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A206751-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206751-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206751-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206751-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206751-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206751-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206751-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206751-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A206751-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206751-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206751-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206751-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206751-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206751-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206751-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206751-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206751-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206751-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206751-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206751-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206751-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206751-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206751-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206751-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206751-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206751-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206751-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206751-004 | AB | 1 | 2680178bc6a6… |
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
- methylprednisolone
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| METHYLPREDNISOLONE | 4 mg/1 |
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 |
|---|---|---|---|---|---|---|
| methylprednisolone | METHYLPREDNISOLONE | BluePoint Laboratories | 7092df48-4904-4047-9916-e585417a216f | 2026-05-22 | Warnings, Adverse reactions | 206751 ANDA206751 |
| methylprednisolone | METHYLPREDNISOLONE | A-S Medication Solutions | 646bb826-8d5a-4b03-adfb-ed45daa86d44 | 2026-03-07 | Warnings, Adverse reactions | 206751 ANDA206751 |
| methylprednisolone | METHYLPREDNISOLONE | Major Pharmaceuticals | 3885151c-963e-4d22-b5b4-58968503ad8c | 2025-12-26 | Warnings, Adverse reactions | 206751 ANDA206751 |
| methylprednisolone | METHYLPREDNISOLONE | Zydus Pharmaceuticals USA Inc. | eaa9c932-c659-4ef6-bf5a-186545d87320 | 2025-11-10 | Warnings, Adverse reactions | 206751 ANDA206751 |
| Methylprednisolone | METHYLPREDNISOLONE | Advanced Rx Pharmacy of Tennessee, LLC | f19f6120-3c25-2a28-e053-2a95a90a86d5 | 2024-12-31 | Warnings, Adverse reactions | 206751 ANDA206751 |
| methylprednisolone | METHYLPREDNISOLONE | Zydus Lifesciences Limited | fe9c15b5-4264-45f1-87b5-f7e1d6e6ddee | 2024-12-05 | 206751 ANDA206751 | |
| methylprednisolone | METHYLPREDNISOLONE | Proficient Rx LP | 177fd649-4339-4bfd-bd12-7e8de302412b | 2023-09-01 | Warnings, Adverse reactions | 206751 ANDA206751 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70518-3622-1 | 70518362201 | 21 TABLET in 1 BOTTLE, PLASTIC (70518-3622-1) | 21 tablet | 2026-10-09 | No | No | Current |