hydrocortisone

Generic: hydrocortisone

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone
Generic Name hydrocortisone
Labeler major pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydrocortisone 10 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7188
Product ID 0904-7188_7bba3c72-7a81-48be-9a75-5ba35b8877d3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040646
Listing Expiration 2026-12-31
Marketing Start 2007-03-30

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 09047188
Hyphenated Format 0904-7188

Supplemental Identifiers

RxCUI
197782
UNII
WI4X0X7BPJ
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 hydrocortisone (source: ndc)
Generic Name hydrocortisone (source: ndc)
Application Number ANDA040646 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-7188-61) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7188-61 100 BLISTER PACK in 1 CARTON (0904-7188-61) / 1 TABLET in 1 BLISTER PACK

Ingredients (1)

hydrocortisone (10 mg/1)

Linked Drug Pages (1)

HYDROCORTISONE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7bba3c72-7a81-48be-9a75-5ba35b8877d3", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["197782"], "spl_set_id": ["91885fc8-876f-4a4d-8ae5-eb246a335808"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-7188-61)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-7188-61", "marketing_start_date": "20070330"}], "brand_name": "HYDROCORTISONE", "product_id": "0904-7188_7bba3c72-7a81-48be-9a75-5ba35b8877d3", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0904-7188", "generic_name": "hydrocortisone", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDROCORTISONE", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "10 mg/1"}], "application_number": "ANDA040646", "marketing_category": "ANDA", "marketing_start_date": "20070330", "listing_expiration_date": "20261231"}