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 CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone butyrate 1 mg/g

Manufacturer
Oceanside Pharmaceuticals

Identifiers & Regulatory

Product NDC 68682-384
Product ID 68682-384_36d82d8e-8303-bf39-e063-6394a90a2fab
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020769
Listing Expiration 2026-12-31
Marketing Start 2013-07-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68682384
Hyphenated Format 68682-384

Supplemental Identifiers

RxCUI
1370770
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 NDA020769 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (68682-384-45) / 45 g in 1 TUBE
  • 1 TUBE in 1 CARTON (68682-384-60) / 60 g in 1 TUBE
source: ndc

Packages (2)

68682-384-45 1 TUBE in 1 CARTON (68682-384-45) / 45 g in 1 TUBE 68682-384-60 1 TUBE in 1 CARTON (68682-384-60) / 60 g in 1 TUBE

Ingredients (1)

hydrocortisone butyrate (1 mg/g)

Linked Drug Pages (1)

Hydrocortisone Butyrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "36d82d8e-8303-bf39-e063-6394a90a2fab", "openfda": {"unii": ["05RMF7YPWN"], "rxcui": ["1370770"], "spl_set_id": ["ddf699f4-1ae0-48c3-8d2a-56aa1a2c5bc1"], "manufacturer_name": ["Oceanside Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (68682-384-45)  / 45 g in 1 TUBE", "package_ndc": "68682-384-45", "marketing_start_date": "20130703"}, {"sample": false, "description": "1 TUBE in 1 CARTON (68682-384-60)  / 60 g in 1 TUBE", "package_ndc": "68682-384-60", "marketing_start_date": "20130703"}], "brand_name": "Hydrocortisone Butyrate", "product_id": "68682-384_36d82d8e-8303-bf39-e063-6394a90a2fab", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68682-384", "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/g"}], "application_number": "NDA020769", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20130703", "listing_expiration_date": "20261231"}