methylprednisolone sodium succinate (63323-258)

Drug Facts

Product Profile

Brand Name methylprednisolone sodium succinate

Generic Name methylprednisolone sodium succinate

Labeler fresenius kabi usa, llc

Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Routes

INTRAMUSCULAR INTRAVENOUS

Active Ingredients

methylprednisolone sodium succinate 125 mg/2mL

Manufacturer

Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-258

Product ID 63323-258_dc369096-3042-4942-9aeb-bbdf98f35bb8

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA040583

Listing Expiration 2026-12-31

Marketing Start 2004-11-30

Pharmacologic Class

Classes

corticosteroid hormone receptor agonists [moa] corticosteroid [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323258

Hyphenated Format 63323-258

Supplemental Identifiers

RxCUI

311659 314099 1743704

UPC

0363323255015 0363323265304 0363323258016

UNII

LEC9GKY20K

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 sodium succinate (source: ndc)

Generic Name methylprednisolone sodium succinate (source: ndc)

Application Number ANDA040583 (source: ndc)

Routes

INTRAMUSCULAR INTRAVENOUS

source: ndc

Resolved Composition

Strengths

125 mg/2mL

source: ndc

Packaging

25 VIAL, SINGLE-DOSE in 1 TRAY (63323-258-03) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-258-01)

source: ndc

Packages (1)

63323-258-03 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-258-03) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-258-01)

Ingredients (1)

methylprednisolone sodium succinate (125 mg/2mL)

Linked Drug Pages (1)

Methylprednisolone Sodium Succinate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "dc369096-3042-4942-9aeb-bbdf98f35bb8", "openfda": {"upc": ["0363323255015", "0363323265304", "0363323258016"], "unii": ["LEC9GKY20K"], "rxcui": ["311659", "314099", "1743704"], "spl_set_id": ["c5d22210-73c6-4697-a267-75e243508642"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 TRAY (63323-258-03)  / 2 mL in 1 VIAL, SINGLE-DOSE (63323-258-01)", "package_ndc": "63323-258-03", "marketing_start_date": "20041130"}], "brand_name": "Methylprednisolone Sodium Succinate", "product_id": "63323-258_dc369096-3042-4942-9aeb-bbdf98f35bb8", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "63323-258", "generic_name": "METHYLPREDNISOLONE SODIUM SUCCINATE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylprednisolone Sodium Succinate", "active_ingredients": [{"name": "METHYLPREDNISOLONE SODIUM SUCCINATE", "strength": "125 mg/2mL"}], "application_number": "ANDA040583", "marketing_category": "ANDA", "marketing_start_date": "20041130", "listing_expiration_date": "20261231"}