Home NDC 59762-0050-1 Methylprednisolone
Product NDC 59762-0050
Requested package NDC 59762-0050-1
11-digit product format 597620050
Labeler code 59762
Product ID 59762-0050_bc3419a0-22a3-4eaf-a4f2-3133e9380663
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name methylprednisolone
Dosage form TABLET
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application NDA011153
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2013-03-25
Substance METHYLPREDNISOLONE
Active strength 16 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N011153-001 MEDROL METHYLPREDNISOLONE 4MG TABLET / ORAL AB RLD, Approved before 1982 N011153-002 MEDROL METHYLPREDNISOLONE 2MG TABLET / ORAL RLD, Approved before 1982 N011153-003 MEDROL METHYLPREDNISOLONE 16MG TABLET / ORAL AB RLD, Approved before 1982 N011153-004 MEDROL METHYLPREDNISOLONE 8MG TABLET / ORAL AB RLD, Approved before 1982 N011153-005 MEDROL METHYLPREDNISOLONE 24MG TABLET / ORAL Approved before 1982 N011153-006 MEDROL METHYLPREDNISOLONE 32MG TABLET / ORAL AB RLD, RS, Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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.
Product history page 1 of 7 · 258 observed states.
Captured, Edition, Application-product table 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 N011153-001 MEDROL 4MG TABLET / ORAL AB RLD, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N011153-002 MEDROL 2MG TABLET / ORAL RLD, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N011153-003 MEDROL 16MG TABLET / ORAL AB RLD, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N011153-004 MEDROL 8MG TABLET / ORAL AB RLD, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N011153-005 MEDROL 24MG TABLET / ORAL Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N011153-006 MEDROL 32MG TABLET / ORAL AB RLD, RS, Approved before 1982 84e616aacf4f…2026-08-18 06:07:40 2026-07 N011153-001 MEDROL 4MG TABLET / ORAL AB RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N011153-002 MEDROL 2MG TABLET / ORAL RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N011153-003 MEDROL 16MG TABLET / ORAL AB RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N011153-004 MEDROL 8MG TABLET / ORAL AB RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N011153-005 MEDROL 24MG TABLET / ORAL Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N011153-006 MEDROL 32MG TABLET / ORAL AB RLD, RS, Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N011153-001 MEDROL 4MG TABLET / ORAL AB RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N011153-002 MEDROL 2MG TABLET / ORAL RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N011153-003 MEDROL 16MG TABLET / ORAL AB RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N011153-004 MEDROL 8MG TABLET / ORAL AB RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N011153-005 MEDROL 24MG TABLET / ORAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N011153-006 MEDROL 32MG TABLET / ORAL AB RLD, RS, Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N011153-001 MEDROL 4MG TABLET / ORAL AB RLD, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N011153-002 MEDROL 2MG TABLET / ORAL RLD, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N011153-003 MEDROL 16MG TABLET / ORAL AB RLD, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N011153-004 MEDROL 8MG TABLET / ORAL AB RLD, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N011153-005 MEDROL 24MG TABLET / ORAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N011153-006 MEDROL 32MG TABLET / ORAL AB RLD, RS, Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N011153-001 MEDROL 4MG TABLET / ORAL AB RLD, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N011153-002 MEDROL 2MG TABLET / ORAL RLD, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N011153-003 MEDROL 16MG TABLET / ORAL AB RLD, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N011153-004 MEDROL 8MG TABLET / ORAL AB RLD, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N011153-005 MEDROL 24MG TABLET / ORAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N011153-006 MEDROL 32MG TABLET / ORAL AB RLD, RS, Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N011153-001 MEDROL 4MG TABLET / ORAL AB RLD, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N011153-002 MEDROL 2MG TABLET / ORAL RLD, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N011153-003 MEDROL 16MG TABLET / ORAL AB RLD, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N011153-004 MEDROL 8MG TABLET / ORAL AB RLD, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N011153-005 MEDROL 24MG TABLET / ORAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N011153-006 MEDROL 32MG TABLET / ORAL AB RLD, RS, Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N011153-001 MEDROL 4MG TABLET / ORAL AB RLD, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N011153-002 MEDROL 2MG TABLET / ORAL RLD, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N011153-003 MEDROL 16MG TABLET / ORAL AB RLD, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N011153-004 MEDROL 8MG TABLET / ORAL AB RLD, Approved before 1982 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 191 observed states.
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 table Ingredient Strength METHYLPREDNISOLONE 16 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination X4W7ZR7023 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197971 Internal RxNorm lookup 197973 Internal RxNorm lookup 259966 Internal RxNorm lookup 328161 Internal RxNorm lookup 762675 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59762-0050-1 Methylprednisolone 50 in 1 BOTTLE TABLET 50 19
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59762-0050 METHYLPREDNISOLONE TABLET [MYLAN PHARMACEUTICALS INC.] 18 Current NDC, Legacy NDC, 1 package rows 20250524_22dd75d6-f89a-44f7-8ca6-b64c4e9806dd.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.
Matched openFDA labels page 1 of 1 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59762-0050-1 59762005001 50 TABLET in 1 BOTTLE (59762-0050-1) 50 tablet 2013-03-25 0000-00-00 No No Current