methylprednisolone

Generic: methylprednisolone

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

Drug Facts

Product Profile

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

methylprednisolone 4 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-193
Product ID 76420-193_bda4563a-3fa1-a76b-e053-2995a90a304c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204072
Listing Expiration 2026-12-31
Marketing Start 2018-05-14

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 76420193
Hyphenated Format 76420-193

Supplemental Identifiers

RxCUI
259966 762675
UNII
X4W7ZR7023
NUI
N0000175576 N0000175450

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 ANDA204072 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 21 TABLET in 1 BLISTER PACK (76420-193-21)
source: ndc

Packages (1)

76420-193-21 21 TABLET in 1 BLISTER PACK (76420-193-21)

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": "bda4563a-3fa1-a76b-e053-2995a90a304c", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["X4W7ZR7023"], "rxcui": ["259966", "762675"], "spl_set_id": ["8bff5330-c1f6-4014-aadb-45c1726248dd"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "21 TABLET in 1 BLISTER PACK (76420-193-21)", "package_ndc": "76420-193-21", "marketing_start_date": "20210316"}], "brand_name": "METHYLPREDNISOLONE", "product_id": "76420-193_bda4563a-3fa1-a76b-e053-2995a90a304c", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "76420-193", "generic_name": "METHYLPREDNISOLONE", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METHYLPREDNISOLONE", "active_ingredients": [{"name": "METHYLPREDNISOLONE", "strength": "4 mg/1"}], "application_number": "ANDA204072", "marketing_category": "ANDA", "marketing_start_date": "20180514", "listing_expiration_date": "20261231"}