halcinonide

Generic: halcinonide

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

Drug Facts

Product Profile

Brand Name halcinonide
Generic Name halcinonide
Labeler mylan pharmaceuticals inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

halcinonide 1 mg/g

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-8056
Product ID 0378-8056_09b49bcc-a3cf-4281-a753-65866b2b8c3b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211027
Listing Expiration 2026-12-31
Marketing Start 2019-08-15

Pharmacologic Class

Established (EPC)
corticosteroid [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03788056
Hyphenated Format 0378-8056

Supplemental Identifiers

RxCUI
103467
UNII
SI86V6QNEG
NUI
N0000175576 N0000175450

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 halcinonide (source: ndc)
Generic Name halcinonide (source: ndc)
Application Number ANDA211027 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0378-8056-49) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0378-8056-60) / 60 g in 1 TUBE
source: ndc

Packages (2)

0378-8056-49 1 TUBE in 1 CARTON (0378-8056-49) / 30 g in 1 TUBE 0378-8056-60 1 TUBE in 1 CARTON (0378-8056-60) / 60 g in 1 TUBE

Ingredients (1)

halcinonide (1 mg/g)

Linked Drug Pages (1)

Halcinonide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "09b49bcc-a3cf-4281-a753-65866b2b8c3b", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["SI86V6QNEG"], "rxcui": ["103467"], "spl_set_id": ["b7d78c72-a683-4208-b7dd-5523502c036c"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0378-8056-49)  / 30 g in 1 TUBE", "package_ndc": "0378-8056-49", "marketing_start_date": "20190815"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0378-8056-60)  / 60 g in 1 TUBE", "package_ndc": "0378-8056-60", "marketing_start_date": "20190815"}], "brand_name": "Halcinonide", "product_id": "0378-8056_09b49bcc-a3cf-4281-a753-65866b2b8c3b", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0378-8056", "generic_name": "Halcinonide", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Halcinonide", "active_ingredients": [{"name": "HALCINONIDE", "strength": "1 mg/g"}], "application_number": "ANDA211027", "marketing_category": "ANDA", "marketing_start_date": "20190815", "listing_expiration_date": "20261231"}