flurandrenolide

Generic: flurandrenolide

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name flurandrenolide
Generic Name flurandrenolide
Labeler bryant ranch prepack
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

flurandrenolide .5 mg/mL

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8657
Product ID 63629-8657_00b804f5-7685-0b1d-e063-6294a90a5753
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207133
Listing Expiration 2026-12-31
Marketing Start 2016-10-06

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 636298657
Hyphenated Format 63629-8657

Supplemental Identifiers

RxCUI
197719
UNII
8EUL29XUQT
NUI
N0000175576 N0000175450

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 flurandrenolide (source: ndc)
Generic Name flurandrenolide (source: ndc)
Application Number ANDA207133 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (63629-8657-1) / 120 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

63629-8657-1 1 BOTTLE, PLASTIC in 1 CARTON (63629-8657-1) / 120 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

flurandrenolide (.5 mg/mL)

Linked Drug Pages (1)

Flurandrenolide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "00b804f5-7685-0b1d-e063-6294a90a5753", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["8EUL29XUQT"], "rxcui": ["197719"], "spl_set_id": ["3868377d-bee3-42f4-8c72-319e84e7d5bd"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (63629-8657-1)  / 120 mL in 1 BOTTLE, PLASTIC", "package_ndc": "63629-8657-1", "marketing_start_date": "20161006"}], "brand_name": "Flurandrenolide", "product_id": "63629-8657_00b804f5-7685-0b1d-e063-6294a90a5753", "dosage_form": "LOTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "63629-8657", "generic_name": "Flurandrenolide", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Flurandrenolide", "active_ingredients": [{"name": "FLURANDRENOLIDE", "strength": ".5 mg/mL"}], "application_number": "ANDA207133", "marketing_category": "ANDA", "marketing_start_date": "20161006", "listing_expiration_date": "20261231"}