methylprednisolone

Generic: methylprednisolone

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methylprednisolone
Generic Name methylprednisolone
Labeler bluepoint laboratories
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methylprednisolone 8 mg/1

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-558
Product ID 68001-558_38f61d6e-960d-3735-e063-6394a90a055c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040189
Marketing Start 2023-01-31
Marketing End 2026-03-31

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 68001558
Hyphenated Format 68001-558

Supplemental Identifiers

RxCUI
197971 197973 259966 328161 762675
UPC
0368001557009 0368001005012 0368001559690 0368001558556 0368001560559
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 ANDA040189 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 25 TABLET in 1 BOTTLE (68001-558-55)
source: ndc

Packages (1)

68001-558-55 25 TABLET in 1 BOTTLE (68001-558-55)

Ingredients (1)

methylprednisolone (8 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": "38f61d6e-960d-3735-e063-6394a90a055c", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0368001557009", "0368001005012", "0368001559690", "0368001558556", "0368001560559"], "unii": ["X4W7ZR7023"], "rxcui": ["197971", "197973", "259966", "328161", "762675"], "spl_set_id": ["a91f119c-9765-4a6f-b636-4470d11dc3d2"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 TABLET in 1 BOTTLE (68001-558-55)", "package_ndc": "68001-558-55", "marketing_end_date": "20260331", "marketing_start_date": "20230131"}], "brand_name": "Methylprednisolone", "product_id": "68001-558_38f61d6e-960d-3735-e063-6394a90a055c", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68001-558", "generic_name": "Methylprednisolone", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylprednisolone", "active_ingredients": [{"name": "METHYLPREDNISOLONE", "strength": "8 mg/1"}], "application_number": "ANDA040189", "marketing_category": "ANDA", "marketing_end_date": "20260331", "marketing_start_date": "20230131"}