fluocinolone acetonide

Generic: fluocinolone acetonide

Labeler: fougera pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluocinolone acetonide
Generic Name fluocinolone acetonide
Labeler fougera pharmaceuticals, llc
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

fluocinolone acetonide .1 mg/mL

Manufacturer
Fougera Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 0168-0059
Product ID 0168-0059_7c4e6b9b-d444-4afe-a658-cdb4a6205ad2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088167
Listing Expiration 2027-12-31
Marketing Start 1982-12-16

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 01680059
Hyphenated Format 0168-0059

Supplemental Identifiers

RxCUI
1191310
UPC
0301680059600
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 (source: ndc)
Generic Name fluocinolone acetonide (source: ndc)
Application Number ANDA088167 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .1 mg/mL
source: ndc
Packaging
  • 60 mL in 1 BOTTLE (0168-0059-60)
source: ndc

Packages (1)

0168-0059-60 60 mL in 1 BOTTLE (0168-0059-60)

Ingredients (1)

fluocinolone acetonide (.1 mg/mL)

Linked Drug Pages (1)

Fluocinolone Acetonide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "7c4e6b9b-d444-4afe-a658-cdb4a6205ad2", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0301680059600"], "unii": ["0CD5FD6S2M"], "rxcui": ["1191310"], "spl_set_id": ["5649e15a-6a7c-4752-ac28-01e453afb37e"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Fougera Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 mL in 1 BOTTLE (0168-0059-60)", "package_ndc": "0168-0059-60", "marketing_start_date": "19821216"}], "brand_name": "Fluocinolone Acetonide", "product_id": "0168-0059_7c4e6b9b-d444-4afe-a658-cdb4a6205ad2", "dosage_form": "SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0168-0059", "generic_name": "fluocinolone acetonide", "labeler_name": "Fougera Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluocinolone Acetonide", "active_ingredients": [{"name": "FLUOCINOLONE ACETONIDE", "strength": ".1 mg/mL"}], "application_number": "ANDA088167", "marketing_category": "ANDA", "marketing_start_date": "19821216", "listing_expiration_date": "20271231"}