fluocinolone acetonide topical solution usp, 0.01%

Generic: fluocinolone acetonide topical solution usp, 0.01%

Labeler: encube ethicals, inc.
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 encube ethicals, inc.
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

fluocinolone acetonide .1 mg/mL

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-003
Product ID 21922-003_d817827b-8a7c-48c2-a898-59d6569a331c
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 21922003
Hyphenated Format 21922-003

Supplemental Identifiers

RxCUI
1191310
UPC
0321922003017
UNII
0CD5FD6S2M
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 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 (21922-003-01) / 60 mL in 1 BOTTLE
source: ndc

Packages (1)

21922-003-01 1 BOTTLE in 1 CARTON (21922-003-01) / 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": "d817827b-8a7c-48c2-a898-59d6569a331c", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0321922003017"], "unii": ["0CD5FD6S2M"], "rxcui": ["1191310"], "spl_set_id": ["3fb00d90-6a5b-4e95-ab6b-f5b102ff0f36"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Encube Ethicals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (21922-003-01)  / 60 mL in 1 BOTTLE", "package_ndc": "21922-003-01", "marketing_start_date": "20190320"}], "brand_name": "Fluocinolone Acetonide Topical Solution USP, 0.01%", "product_id": "21922-003_d817827b-8a7c-48c2-a898-59d6569a331c", "dosage_form": "SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "21922-003", "generic_name": "Fluocinolone Acetonide Topical Solution USP, 0.01%", "labeler_name": "Encube Ethicals, Inc.", "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"}