hydrocortisone

Generic: antipruritic (anti-itch)

Labeler: bluepoint laboratories
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone
Generic Name antipruritic (anti-itch)
Labeler bluepoint laboratories
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone 1 g/100g

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-476
Product ID 68001-476_09bb7522-4299-8c71-e063-6294a90a0c24
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2020-11-27

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 68001476
Hyphenated Format 68001-476

Supplemental Identifiers

RxCUI
106258
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 antipruritic (anti-itch) (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 g/100g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (68001-476-46) / 30 g in 1 TUBE
  • 454 g in 1 JAR (68001-476-50)
source: ndc

Packages (2)

68001-476-46 1 TUBE in 1 CARTON (68001-476-46) / 30 g in 1 TUBE 68001-476-50 454 g in 1 JAR (68001-476-50)

Ingredients (1)

hydrocortisone (1 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": "09bb7522-4299-8c71-e063-6294a90a0c24", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["106258"], "spl_set_id": ["b505769e-9c46-3cf3-e053-2a95a90a4df9"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (68001-476-46)  / 30 g in 1 TUBE", "package_ndc": "68001-476-46", "marketing_start_date": "20201127"}, {"sample": false, "description": "454 g in 1 JAR (68001-476-50)", "package_ndc": "68001-476-50", "marketing_start_date": "20201127"}], "brand_name": "Hydrocortisone", "product_id": "68001-476_09bb7522-4299-8c71-e063-6294a90a0c24", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68001-476", "generic_name": "Antipruritic (Anti-Itch)", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Hydrocortisone", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "1 g/100g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20201127", "listing_expiration_date": "20261231"}