Home NDC 0009-0022 Medrol
Product NDC 0009-0022
11-digit product format 000090022
Labeler code 0009
Product ID 0009-0022_e4a8e5b4-af77-4eca-92de-cd0982969b82
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name methylprednisolone
Dosage form TABLET
Route ORAL
Labeler Pharmacia & Upjohn Company LLC
Application NDA011153
Marketing category NDA
Marketing start 1957-10-24
Substance METHYLPREDNISOLONE
Active strength 8 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 · 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.
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 2026-08-01 22:54:32 2026-06 N011153-001 MEDROL 4MG TABLET / ORAL AB RLD, Approved before 1982 a50c72e98297…2026-08-01 22:54:32 2026-06 N011153-002 MEDROL 2MG TABLET / ORAL RLD, Approved before 1982 a50c72e98297…2026-08-01 22:54:32 2026-06 N011153-003 MEDROL 16MG TABLET / ORAL AB RLD, Approved before 1982 a50c72e98297…2026-08-01 22:54:32 2026-06 N011153-004 MEDROL 8MG TABLET / ORAL AB RLD, Approved before 1982 a50c72e98297…2026-08-01 22:54:32 2026-06 N011153-005 MEDROL 24MG TABLET / ORAL Approved before 1982 a50c72e98297…2026-08-01 22:54:32 2026-06 N011153-006 MEDROL 32MG TABLET / ORAL AB RLD, RS, Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Medrol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHYLPREDNISOLONE 8 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 · 12 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197969 Internal RxNorm lookup 197971 Internal RxNorm lookup 197973 Internal RxNorm lookup 207136 Internal RxNorm lookup 207137 Internal RxNorm lookup 207138 Internal RxNorm lookup 207141 Internal RxNorm lookup 259966 Internal RxNorm lookup 260330 Internal RxNorm lookup 328161 Internal RxNorm lookup 762675 Internal RxNorm lookup 834023 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 0009-0022-01 Medrol 25 in 1 BOTTLE TABLET 25 25
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0009-0022 MEDROL (METHYLPREDNISOLONE) TABLET [PHARMACIA & UPJOHN COMPANY LLC] 24 Current NDC, Legacy NDC, 1 package rows 20250424_39d5270b-d957-4821-93d6-501b7b9f02d4.zip
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 0009-0022-01 00009002201 25 TABLET in 1 BOTTLE (0009-0022-01) 25 tablet 1957-10-24 0000-00-00 No No Current