hydrocortisone butyrate

Generic: hydrocortisone butyrate

Labeler: taro pharmaceuticals u.s.a., inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone butyrate
Generic Name hydrocortisone butyrate
Labeler taro pharmaceuticals u.s.a., inc.
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

hydrocortisone butyrate 1 mg/mL

Manufacturer
Taro Pharmaceuticals U.S.A., Inc.

Identifiers & Regulatory

Product NDC 51672-4061
Product ID 51672-4061_26e4c766-6315-4c55-9814-181258a45ad5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076364
Listing Expiration 2026-12-31
Marketing Start 2004-01-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516724061
Hyphenated Format 51672-4061

Supplemental Identifiers

RxCUI
1370758 1370767 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 ANDA076364 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (51672-4061-2) / 20 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (51672-4061-4) / 60 mL in 1 BOTTLE
source: ndc

Packages (2)

51672-4061-2 1 BOTTLE in 1 CARTON (51672-4061-2) / 20 mL in 1 BOTTLE 51672-4061-4 1 BOTTLE in 1 CARTON (51672-4061-4) / 60 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": "26e4c766-6315-4c55-9814-181258a45ad5", "openfda": {"unii": ["05RMF7YPWN"], "rxcui": ["1370758", "1370767", "1370770"], "spl_set_id": ["51176835-598d-4da7-8a00-6bd36f52aa82"], "manufacturer_name": ["Taro Pharmaceuticals U.S.A., Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (51672-4061-2)  / 20 mL in 1 BOTTLE", "package_ndc": "51672-4061-2", "marketing_start_date": "20040114"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (51672-4061-4)  / 60 mL in 1 BOTTLE", "package_ndc": "51672-4061-4", "marketing_start_date": "20040114"}], "brand_name": "Hydrocortisone Butyrate", "product_id": "51672-4061_26e4c766-6315-4c55-9814-181258a45ad5", "dosage_form": "SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "51672-4061", "generic_name": "Hydrocortisone Butyrate", "labeler_name": "Taro Pharmaceuticals U.S.A., Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocortisone Butyrate", "active_ingredients": [{"name": "HYDROCORTISONE BUTYRATE", "strength": "1 mg/mL"}], "application_number": "ANDA076364", "marketing_category": "ANDA", "marketing_start_date": "20040114", "listing_expiration_date": "20261231"}