methylprednisolone

Generic: methylprednisolone

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methylprednisolone
Generic Name methylprednisolone
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methylprednisolone 4 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-916
Product ID 68382-916_6cebff10-362f-41a7-8f66-3d9e878760fd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206751
Listing Expiration 2026-12-31
Marketing Start 2018-05-01

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 68382916
Hyphenated Format 68382-916

Supplemental Identifiers

RxCUI
197971 197973 259966 328161 762675
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 ANDA206751 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68382-916-01)
  • 500 TABLET in 1 BOTTLE (68382-916-05)
  • 1 BLISTER PACK in 1 CARTON (68382-916-34) / 21 TABLET in 1 BLISTER PACK
source: ndc

Packages (3)

68382-916-01 100 TABLET in 1 BOTTLE (68382-916-01) 68382-916-05 500 TABLET in 1 BOTTLE (68382-916-05) 68382-916-34 1 BLISTER PACK in 1 CARTON (68382-916-34) / 21 TABLET in 1 BLISTER PACK

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": "6cebff10-362f-41a7-8f66-3d9e878760fd", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["X4W7ZR7023"], "rxcui": ["197971", "197973", "259966", "328161", "762675"], "spl_set_id": ["eaa9c932-c659-4ef6-bf5a-186545d87320"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68382-916-01)", "package_ndc": "68382-916-01", "marketing_start_date": "20180501"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (68382-916-05)", "package_ndc": "68382-916-05", "marketing_start_date": "20180501"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (68382-916-34)  / 21 TABLET in 1 BLISTER PACK", "package_ndc": "68382-916-34", "marketing_start_date": "20180501"}], "brand_name": "methylprednisolone", "product_id": "68382-916_6cebff10-362f-41a7-8f66-3d9e878760fd", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68382-916", "generic_name": "methylprednisolone", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "methylprednisolone", "active_ingredients": [{"name": "METHYLPREDNISOLONE", "strength": "4 mg/1"}], "application_number": "ANDA206751", "marketing_category": "ANDA", "marketing_start_date": "20180501", "listing_expiration_date": "20261231"}