Home NDC 80425-0230 Methylprednisolone
Product NDC 80425-0230
11-digit product format 804250230
Labeler code 80425
Product ID 80425-0230_2a9b1617-60d1-f8ce-e063-6294a90ab02c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methylprednisolone
Dosage form TABLET
Route ORAL
Labeler Advanced Rx Pharmacy of Tennessee, LLC
Application ANDA040189
Marketing category ANDA
Marketing start 2023-01-11
Substance METHYLPREDNISOLONE
Active strength 4 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040189-001 METHYLPREDNISOLONE METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 A040189-002 METHYLPREDNISOLONE METHYLPREDNISOLONE 8MG TABLET / ORAL AB 1997-10-31 A040189-003 METHYLPREDNISOLONE METHYLPREDNISOLONE 16MG TABLET / ORAL AB 2007-07-20 A040189-004 METHYLPREDNISOLONE METHYLPREDNISOLONE 32MG TABLET / ORAL AB 2007-07-20
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 5 · 164 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 2026-02-19 14:30 UTC 2026-02 A040189-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040189-002 METHYLPREDNISOLONE 8MG TABLET / ORAL AB 1997-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040189-003 METHYLPREDNISOLONE 16MG TABLET / ORAL AB 2007-07-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040189-004 METHYLPREDNISOLONE 32MG TABLET / ORAL AB 2007-07-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040189-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040189-002 METHYLPREDNISOLONE 8MG TABLET / ORAL AB 1997-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040189-003 METHYLPREDNISOLONE 16MG TABLET / ORAL AB 2007-07-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040189-004 METHYLPREDNISOLONE 32MG TABLET / ORAL AB 2007-07-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040189-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040189-002 METHYLPREDNISOLONE 8MG TABLET / ORAL AB 1997-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040189-003 METHYLPREDNISOLONE 16MG TABLET / ORAL AB 2007-07-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040189-004 METHYLPREDNISOLONE 32MG TABLET / ORAL AB 2007-07-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040189-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040189-002 METHYLPREDNISOLONE 8MG TABLET / ORAL AB 1997-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040189-003 METHYLPREDNISOLONE 16MG TABLET / ORAL AB 2007-07-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040189-004 METHYLPREDNISOLONE 32MG TABLET / ORAL AB 2007-07-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040189-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040189-002 METHYLPREDNISOLONE 8MG TABLET / ORAL AB 1997-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040189-003 METHYLPREDNISOLONE 16MG TABLET / ORAL AB 2007-07-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040189-004 METHYLPREDNISOLONE 32MG TABLET / ORAL AB 2007-07-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040189-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040189-002 METHYLPREDNISOLONE 8MG TABLET / ORAL AB 1997-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040189-003 METHYLPREDNISOLONE 16MG TABLET / ORAL AB 2007-07-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040189-004 METHYLPREDNISOLONE 32MG TABLET / ORAL AB 2007-07-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040189-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040189-002 METHYLPREDNISOLONE 8MG TABLET / ORAL AB 1997-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040189-003 METHYLPREDNISOLONE 16MG TABLET / ORAL AB 2007-07-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040189-004 METHYLPREDNISOLONE 32MG TABLET / ORAL AB 2007-07-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040189-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040189-002 METHYLPREDNISOLONE 8MG TABLET / ORAL AB 1997-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040189-003 METHYLPREDNISOLONE 16MG TABLET / ORAL AB 2007-07-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040189-004 METHYLPREDNISOLONE 32MG TABLET / ORAL AB 2007-07-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040189-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040189-002 METHYLPREDNISOLONE 8MG TABLET / ORAL AB 1997-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040189-003 METHYLPREDNISOLONE 16MG TABLET / ORAL AB 2007-07-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040189-004 METHYLPREDNISOLONE 32MG TABLET / ORAL AB 2007-07-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040189-001 METHYLPREDNISOLONE 4MG TABLET / ORAL AB 1997-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040189-002 METHYLPREDNISOLONE 8MG TABLET / ORAL AB 1997-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040189-003 METHYLPREDNISOLONE 16MG TABLET / ORAL AB 2007-07-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040189-004 METHYLPREDNISOLONE 32MG TABLET / ORAL AB 2007-07-20 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Methylprednisolone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHYLPREDNISOLONE 4 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 259966 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 80425-0230-1 Methylprednisolone 21 in 1 BLISTER PACK TABLET 21 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80425-0230 METHYLPREDNISOLONE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC] 3 Current NDC, 1 package rows 20250102_f19f3676-856f-e8d7-e053-2995a90ad703.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 Sample Exclude flag Status 80425-0230-1 80425023001 21 TABLET in 1 BLISTER PACK (80425-0230-1) 21 tablet 2023-01-11 No No Current