hydrocortisone

Generic: hydrocortisone

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone
Generic Name hydrocortisone
Labeler sun pharmaceutical industries, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone .5 g/100g

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-2010
Product ID 51672-2010_390d0eb8-c4dc-e391-e063-6394a90a7333
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2001-09-13

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 516722010
Hyphenated Format 51672-2010

Supplemental Identifiers

RxCUI
198707
UNII
WI4X0X7BPJ
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 hydrocortisone (source: ndc)
Generic Name hydrocortisone (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 g/100g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (51672-2010-2) / 28.4 g in 1 TUBE
source: ndc

Packages (1)

51672-2010-2 1 TUBE in 1 CARTON (51672-2010-2) / 28.4 g in 1 TUBE

Ingredients (1)

hydrocortisone (.5 g/100g)

Linked Drug Pages (1)

Hydrocortisone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "390d0eb8-c4dc-e391-e063-6394a90a7333", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["198707"], "spl_set_id": ["2ada9ec2-1c28-4da2-8639-07b3193ffb32"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (51672-2010-2)  / 28.4 g in 1 TUBE", "package_ndc": "51672-2010-2", "marketing_start_date": "20010913"}], "brand_name": "Hydrocortisone", "product_id": "51672-2010_390d0eb8-c4dc-e391-e063-6394a90a7333", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "51672-2010", "generic_name": "Hydrocortisone", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Hydrocortisone", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": ".5 g/100g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20010913", "listing_expiration_date": "20261231"}