hydrocortisone butyrate

Generic: hydrocortisone butyrate

Labeler: oceanside pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone butyrate
Generic Name hydrocortisone butyrate
Labeler oceanside pharmaceuticals
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

hydrocortisone butyrate 1 mg/mL

Manufacturer
Oceanside Pharmaceuticals

Identifiers & Regulatory

Product NDC 68682-392
Product ID 68682-392_2f38330f-dede-a2af-e063-6294a90a1a94
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA022076
Listing Expiration 2026-12-31
Marketing Start 2018-06-08

Pharmacologic Class

Classes
corticosteroid hormone receptor agonists [moa] corticosteroid [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68682392
Hyphenated Format 68682-392

Supplemental Identifiers

RxCUI
1370763
UNII
05RMF7YPWN

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 butyrate (source: ndc)
Generic Name hydrocortisone butyrate (source: ndc)
Application Number NDA022076 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (68682-392-02) / 59 mL in 1 BOTTLE
source: ndc

Packages (1)

68682-392-02 1 BOTTLE in 1 CARTON (68682-392-02) / 59 mL in 1 BOTTLE

Ingredients (1)

hydrocortisone butyrate (1 mg/mL)

Linked Drug Pages (1)

HYDROCORTISONE BUTYRATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "2f38330f-dede-a2af-e063-6294a90a1a94", "openfda": {"unii": ["05RMF7YPWN"], "rxcui": ["1370763"], "spl_set_id": ["dde66620-657b-4b30-bd30-4bb6e83612cb"], "manufacturer_name": ["Oceanside Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68682-392-02)  / 59 mL in 1 BOTTLE", "package_ndc": "68682-392-02", "marketing_start_date": "20180608"}], "brand_name": "HYDROCORTISONE BUTYRATE", "product_id": "68682-392_2f38330f-dede-a2af-e063-6294a90a1a94", "dosage_form": "LOTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68682-392", "generic_name": "HYDROCORTISONE BUTYRATE", "labeler_name": "Oceanside Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDROCORTISONE BUTYRATE", "active_ingredients": [{"name": "HYDROCORTISONE BUTYRATE", "strength": "1 mg/mL"}], "application_number": "NDA022076", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20180608", "listing_expiration_date": "20261231"}