kera hc

Generic: hydrocortisone

Labeler: clinical therapeutic solutions
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name kera hc
Generic Name hydrocortisone
Labeler clinical therapeutic solutions
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone 1 g/100g

Manufacturer
Clinical Therapeutic Solutions

Identifiers & Regulatory

Product NDC 44577-623
Product ID 44577-623_09d72089-c2ef-70f3-e063-6394a90a65ad
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2012-10-17

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 44577623
Hyphenated Format 44577-623

Supplemental Identifiers

RxCUI
106258 1314932
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 kera hc (source: ndc)
Generic Name hydrocortisone (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 g/100g
source: ndc
Packaging
  • 56 g in 1 TUBE (44577-623-02)
source: ndc

Packages (1)

44577-623-02 56 g in 1 TUBE (44577-623-02)

Ingredients (1)

hydrocortisone (1 g/100g)

Linked Drug Pages (1)

KERA HC ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "09d72089-c2ef-70f3-e063-6394a90a65ad", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["106258", "1314932"], "spl_set_id": ["ac215c8f-b224-480c-9295-3a34316293ba"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Clinical Therapeutic Solutions"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "56 g in 1 TUBE (44577-623-02)", "package_ndc": "44577-623-02", "marketing_start_date": "20170206"}], "brand_name": "KERA HC", "product_id": "44577-623_09d72089-c2ef-70f3-e063-6394a90a65ad", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "44577-623", "generic_name": "HYDROCORTISONE", "labeler_name": "Clinical Therapeutic Solutions", "product_type": "HUMAN OTC DRUG", "brand_name_base": "KERA HC", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "1 g/100g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20121017", "listing_expiration_date": "20261231"}