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 20 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-407
Product ID 50268-407_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 50268407
Hyphenated Format 50268-407

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
  • 20 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-407-15) / 1 TABLET in 1 BLISTER PACK (50268-407-11)
source: ndc

Packages (1)

50268-407-15 50 BLISTER PACK in 1 BOX (50268-407-15) / 1 TABLET in 1 BLISTER PACK (50268-407-11)

Ingredients (1)

hydrocortisone (20 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 (50268-407-15)  / 1 TABLET in 1 BLISTER PACK (50268-407-11)", "package_ndc": "50268-407-15", "marketing_start_date": "20230131"}], "brand_name": "HYDROCORTISONE", "product_id": "50268-407_2b497b3c-577d-f786-e063-6294a90ad095", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "50268-407", "generic_name": "hydrocortisone", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDROCORTISONE", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "20 mg/1"}], "application_number": "ANDA040646", "marketing_category": "ANDA", "marketing_start_date": "20230131", "listing_expiration_date": "20261231"}