methylprednisolone

Generic: methylprednisolone

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methylprednisolone
Generic Name methylprednisolone
Labeler endo usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methylprednisolone 4 mg/1

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 0603-4593
Product ID 0603-4593_6b210f06-32c0-450a-ad2b-2d0827b06f7a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040183
Listing Expiration 2026-12-31
Marketing Start 1998-12-22

Pharmacologic Class

Established (EPC)
corticosteroid [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06034593
Hyphenated Format 0603-4593

Supplemental Identifiers

RxCUI
259966 762675
UPC
0306034593212
UNII
X4W7ZR7023
NUI
N0000175576 N0000175450

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name methylprednisolone (source: ndc)
Generic Name methylprednisolone (source: ndc)
Application Number ANDA040183 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 1 DOSE PACK in 1 CARTON (0603-4593-15) / 21 TABLET in 1 DOSE PACK
  • 100 TABLET in 1 BOTTLE, PLASTIC (0603-4593-21)
source: ndc

Packages (2)

0603-4593-15 1 DOSE PACK in 1 CARTON (0603-4593-15) / 21 TABLET in 1 DOSE PACK 0603-4593-21 100 TABLET in 1 BOTTLE, PLASTIC (0603-4593-21)

Ingredients (1)

methylprednisolone (4 mg/1)

Linked Drug Pages (1)

MethylPREDNISolone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6b210f06-32c0-450a-ad2b-2d0827b06f7a", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0306034593212"], "unii": ["X4W7ZR7023"], "rxcui": ["259966", "762675"], "spl_set_id": ["c84cf5e6-746d-41fb-b3d8-2c0b8ba989af"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 DOSE PACK in 1 CARTON (0603-4593-15)  / 21 TABLET in 1 DOSE PACK", "package_ndc": "0603-4593-15", "marketing_start_date": "19981222"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0603-4593-21)", "package_ndc": "0603-4593-21", "marketing_start_date": "19981222"}], "brand_name": "MethylPREDNISolone", "product_id": "0603-4593_6b210f06-32c0-450a-ad2b-2d0827b06f7a", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0603-4593", "generic_name": "methylprednisolone", "labeler_name": "Endo USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MethylPREDNISolone", "active_ingredients": [{"name": "METHYLPREDNISOLONE", "strength": "4 mg/1"}], "application_number": "ANDA040183", "marketing_category": "ANDA", "marketing_start_date": "19981222", "listing_expiration_date": "20261231"}