hydrocortisone

Generic: hydrocortisone

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone
Generic Name hydrocortisone
Labeler asclemed usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydrocortisone 5 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-028
Product ID 76420-028_ead13f84-4320-7125-e053-2995a90a9bd2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA008697
Listing Expiration 2026-12-31
Marketing Start 2013-02-20

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 76420028
Hyphenated Format 76420-028

Supplemental Identifiers

RxCUI
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 NDA008697 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 50 TABLET in 1 BOTTLE (76420-028-50)
  • 90 TABLET in 1 BOTTLE (76420-028-90)
source: ndc

Packages (2)

76420-028-50 50 TABLET in 1 BOTTLE (76420-028-50) 76420-028-90 90 TABLET in 1 BOTTLE (76420-028-90)

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": "ead13f84-4320-7125-e053-2995a90a9bd2", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["197787"], "spl_set_id": ["459a9907-1261-4a75-8388-f0e2f466939c"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "50 TABLET in 1 BOTTLE (76420-028-50)", "package_ndc": "76420-028-50", "marketing_start_date": "20191224"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (76420-028-90)", "package_ndc": "76420-028-90", "marketing_start_date": "20191224"}], "brand_name": "Hydrocortisone", "product_id": "76420-028_ead13f84-4320-7125-e053-2995a90a9bd2", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "76420-028", "generic_name": "hydrocortisone", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocortisone", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "5 mg/1"}], "application_number": "NDA008697", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20130220", "listing_expiration_date": "20261231"}