hydrocortisone butyrate

Generic: hydrocortisone butyrate

Labeler: the j. molner company llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone butyrate
Generic Name hydrocortisone butyrate
Labeler the j. molner company llc
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

hydrocortisone butyrate 1 mg/mL

Manufacturer
The J. Molner Company LLC

Identifiers & Regulatory

Product NDC 83148-012
Product ID 83148-012_407bc1b6-5851-1b87-e063-6294a90a02da
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209556
Listing Expiration 2026-12-31
Marketing Start 2023-11-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83148012
Hyphenated Format 83148-012

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 ANDA209556 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (83148-012-02) / 59 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (83148-012-04) / 118 mL in 1 BOTTLE
source: ndc

Packages (2)

83148-012-02 1 BOTTLE in 1 CARTON (83148-012-02) / 59 mL in 1 BOTTLE 83148-012-04 1 BOTTLE in 1 CARTON (83148-012-04) / 118 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": "407bc1b6-5851-1b87-e063-6294a90a02da", "openfda": {"unii": ["05RMF7YPWN"], "rxcui": ["1370763"], "spl_set_id": ["160c463e-80d2-4bca-8b7f-42279617e309"], "manufacturer_name": ["The J. Molner Company LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (83148-012-02)  / 59 mL in 1 BOTTLE", "package_ndc": "83148-012-02", "marketing_start_date": "20231106"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (83148-012-04)  / 118 mL in 1 BOTTLE", "package_ndc": "83148-012-04", "marketing_start_date": "20231106"}], "brand_name": "Hydrocortisone Butyrate", "product_id": "83148-012_407bc1b6-5851-1b87-e063-6294a90a02da", "dosage_form": "LOTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "83148-012", "generic_name": "Hydrocortisone Butyrate", "labeler_name": "The J. Molner Company LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocortisone Butyrate", "active_ingredients": [{"name": "HYDROCORTISONE BUTYRATE", "strength": "1 mg/mL"}], "application_number": "ANDA209556", "marketing_category": "ANDA", "marketing_start_date": "20231106", "listing_expiration_date": "20261231"}