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Hydrocortisone Butyrate

Prescription ANDA TE AB Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Hydrocortisone Butyrate
Generic name
Hydrocortisone Butyrate
Dosage form
Ointment
Route
Topical
Marketing category
ANDA · ANDA
Labeler
Sun Pharmaceutical Industries, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
2
Packages
7
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Hydrocortisone Butyrate 1 mg/g 1370763 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Ointment
Route of administration
Topical
Presentations
9

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Corticosteroid Hormone Receptor Agonists [MoA] MoA All 215 members
Corticosteroid [EPC] EPC All 215 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
076842
Application type
ANDA · Abbreviated New Drug Application
Approval date
December 27, 2004
Sponsor
TARO
Products on application
1
Submissions recorded
1
Products approved under application 076842.
Product Trade name Form Strength Ingredient Status TE Flags
076842-001 HYDROCORTISONE BUTYRATE OINTMENT HYDROCORTISONE BUTYRATE Prescription AB RS

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
No
Reference Standard
Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 076842.
Type No. Action Status Date Review
Original application 1 Approved December 27, 2004 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20201231). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN PRESCRIPTION DRUG · 20201231

Indications and Usage

openFDA Drug Labeling

INDICATIONS AND USAGE Hydrocortisone Butyrate Ointment, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Dosage and Administration

openFDA Drug Labeling

DOSAGE AND ADMINISTRATION Hydrocortisone Butyrate Ointment, 0.1% should be applied to the affected areas as a thin layer 2 or 3 times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

Contraindications

openFDA Drug Labeling

CONTRAINDICATIONS None.

Adverse Reactions

openFDA Drug Labeling

ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Description

openFDA Drug Labeling

DESCRIPTION Hydrocortisone Butyrate Ointment, 0.1% contains the topical corticosteroid, hydrocortisone butyrate, a non-fluorinated hydrocortisone ester. It has the chemical name: 11β,17,21-Trihydroxypregn-4-ene-3,20-dione 17-butyrate; the molecular formula: C 25 H 36 O 6 ; the molecular weight: 432.54; and the CAS registry number: 13609-67-1. Its structural formula is: Each gram of Hydrocortisone Butyrate Ointment contains 1 mg of hydrocortisone butyrate in a base consisting of mineral oil and polyethylene. hydrocortisone-butyrate-figure-1-hydrocortisone_butyrate_structure.jpg

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Hydrocortisone Butyrate Ointment, 0.1% is supplied in tubes containing: 15 g (NDC 68682-271-15) 45 g (NDC 68682-271-45)

Adverse event reports

Source: openFDA FAERS
1,910
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: HYDROCORTISONE BUTYRATE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
68682-271-15 68682-271 Oceanside Pharmaceuticals 1 TUBE in 1 CARTON (68682-271-15) / 15 g in 1 TUBE September 1, 2009
68682-271-45 68682-271 Oceanside Pharmaceuticals 1 TUBE in 1 CARTON (68682-271-45) / 45 g in 1 TUBE September 1, 2009
51672-4083-1 51672-4083 Sun Pharmaceutical Industries, Inc. 1 TUBE in 1 CARTON (51672-4083-1) / 15 g in 1 TUBE December 27, 2004
51672-4083-2 51672-4083 Sun Pharmaceutical Industries, Inc. 1 TUBE in 1 CARTON (51672-4083-2) / 30 g in 1 TUBE December 27, 2004
51672-4083-5 51672-4083 Sun Pharmaceutical Industries, Inc. 5 g in 1 TUBE (51672-4083-5) December 27, 2004
51672-4083-6 51672-4083 Sun Pharmaceutical Industries, Inc. 1 TUBE in 1 CARTON (51672-4083-6) / 45 g in 1 TUBE December 27, 2004
51672-4083-7 51672-4083 Sun Pharmaceutical Industries, Inc. 1 TUBE in 1 CARTON (51672-4083-7) / 10 g in 1 TUBE December 27, 2004
68682-271 68682-271 Oceanside Pharmaceuticals — September 1, 2009
51672-4083 51672-4083 Sun Pharmaceutical Industries, Inc. — December 27, 2004

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 12 sections on this page.