fluocinolone acetonide topical solution usp, 0.01%

Generic: fluocinolone acetonide topical solution usp, 0.01%

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

Drug Facts

Product Profile

Brand Name fluocinolone acetonide topical solution usp, 0.01%
Generic Name fluocinolone acetonide topical solution usp, 0.01%
Labeler bryant ranch prepack
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

fluocinolone acetonide .1 mg/mL

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-9584
Product ID 63629-9584_266c3c51-3913-4823-812b-7704a2caa570
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209913
Listing Expiration 2026-12-31
Marketing Start 2019-03-20

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 636299584
Hyphenated Format 63629-9584

Supplemental Identifiers

RxCUI
1191310
UNII
0CD5FD6S2M
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 fluocinolone acetonide topical solution usp, 0.01% (source: ndc)
Generic Name fluocinolone acetonide topical solution usp, 0.01% (source: ndc)
Application Number ANDA209913 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (63629-9584-1) / 60 mL in 1 BOTTLE
source: ndc

Packages (1)

63629-9584-1 1 BOTTLE in 1 CARTON (63629-9584-1) / 60 mL in 1 BOTTLE

Ingredients (1)

fluocinolone acetonide (.1 mg/mL)

Linked Drug Pages (1)

Fluocinolone Acetonide Topical Solution USP, 0.01% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "266c3c51-3913-4823-812b-7704a2caa570", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["0CD5FD6S2M"], "rxcui": ["1191310"], "spl_set_id": ["ce89966d-d7ea-4986-936e-6d46aee497cd"], "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 in 1 CARTON (63629-9584-1)  / 60 mL in 1 BOTTLE", "package_ndc": "63629-9584-1", "marketing_start_date": "20221212"}], "brand_name": "Fluocinolone Acetonide Topical Solution USP, 0.01%", "product_id": "63629-9584_266c3c51-3913-4823-812b-7704a2caa570", "dosage_form": "SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "63629-9584", "generic_name": "Fluocinolone Acetonide Topical Solution USP, 0.01%", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluocinolone Acetonide Topical Solution USP, 0.01%", "active_ingredients": [{"name": "FLUOCINOLONE ACETONIDE", "strength": ".1 mg/mL"}], "application_number": "ANDA209913", "marketing_category": "ANDA", "marketing_start_date": "20190320", "listing_expiration_date": "20261231"}