hydrocortisone

Generic: hydrocortisone

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

hydrocortisone 5 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-405
Product ID 50268-405_2b497b3c-577d-f786-e063-6294a90ad095
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040646
Listing Expiration 2026-12-31
Marketing Start 2023-01-31

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 50268405
Hyphenated Format 50268-405

Supplemental Identifiers

RxCUI
197782 197783 197787
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
  • 5 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-405-15) / 1 TABLET in 1 BLISTER PACK (50268-405-11)
source: ndc

Packages (1)

50268-405-15 50 BLISTER PACK in 1 BOX (50268-405-15) / 1 TABLET in 1 BLISTER PACK (50268-405-11)

Ingredients (1)

hydrocortisone (5 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": "2b497b3c-577d-f786-e063-6294a90ad095", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["197782", "197783", "197787"], "spl_set_id": ["f3956208-291c-7374-e053-2a95a90a4628"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-405-15)  / 1 TABLET in 1 BLISTER PACK (50268-405-11)", "package_ndc": "50268-405-15", "marketing_start_date": "20230131"}], "brand_name": "HYDROCORTISONE", "product_id": "50268-405_2b497b3c-577d-f786-e063-6294a90ad095", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "50268-405", "generic_name": "hydrocortisone", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDROCORTISONE", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "5 mg/1"}], "application_number": "ANDA040646", "marketing_category": "ANDA", "marketing_start_date": "20230131", "listing_expiration_date": "20261231"}