hydrocortisone butyrate

Generic: hydrocortisone butyrate

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone butyrate
Generic Name hydrocortisone butyrate
Labeler lupin pharmaceuticals, inc.
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

hydrocortisone butyrate 1 mg/mL

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-951
Product ID 68180-951_ae94a872-5187-4e85-b573-5e9ee9610bff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210209
Listing Expiration 2027-12-31
Marketing Start 2018-08-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180951
Hyphenated Format 68180-951

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 ANDA210209 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (68180-951-01) / 59 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (68180-951-02) / 118 mL in 1 BOTTLE
source: ndc

Packages (2)

68180-951-01 1 BOTTLE in 1 CARTON (68180-951-01) / 59 mL in 1 BOTTLE 68180-951-02 1 BOTTLE in 1 CARTON (68180-951-02) / 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": "ae94a872-5187-4e85-b573-5e9ee9610bff", "openfda": {"unii": ["05RMF7YPWN"], "rxcui": ["1370763"], "spl_set_id": ["275f3fcf-1170-4df0-9a8d-1482bda409cb"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68180-951-01)  / 59 mL in 1 BOTTLE", "package_ndc": "68180-951-01", "marketing_start_date": "20180817"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (68180-951-02)  / 118 mL in 1 BOTTLE", "package_ndc": "68180-951-02", "marketing_start_date": "20180817"}], "brand_name": "Hydrocortisone Butyrate", "product_id": "68180-951_ae94a872-5187-4e85-b573-5e9ee9610bff", "dosage_form": "LOTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68180-951", "generic_name": "Hydrocortisone Butyrate", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocortisone Butyrate", "active_ingredients": [{"name": "HYDROCORTISONE BUTYRATE", "strength": "1 mg/mL"}], "application_number": "ANDA210209", "marketing_category": "ANDA", "marketing_start_date": "20180817", "listing_expiration_date": "20271231"}