fluocinolone acetonide

Generic: fluocinolone acetonide

Labeler: e. fougera & co. a division of fougera pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluocinolone acetonide
Generic Name fluocinolone acetonide
Labeler e. fougera & co. a division of fougera pharmaceuticals, llc
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

fluocinolone acetonide .25 mg/g

Manufacturer
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 0168-0064
Product ID 0168-0064_2034c4ef-c138-44bd-9101-a7b7660f9d18
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088168
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 01680064
Hyphenated Format 0168-0064

Supplemental Identifiers

RxCUI
1191256
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 ANDA088168 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .25 mg/g
source: ndc
Packaging
  • 15 g in 1 TUBE (0168-0064-15)
  • 60 g in 1 TUBE (0168-0064-60)
source: ndc

Packages (2)

0168-0064-15 15 g in 1 TUBE (0168-0064-15) 0168-0064-60 60 g in 1 TUBE (0168-0064-60)

Ingredients (1)

fluocinolone acetonide (.25 mg/g)

Linked Drug Pages (1)

Fluocinolone Acetonide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "2034c4ef-c138-44bd-9101-a7b7660f9d18", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["0CD5FD6S2M"], "rxcui": ["1191256"], "spl_set_id": ["49552e29-7813-4726-b15d-63bd975b6588"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 g in 1 TUBE (0168-0064-15)", "package_ndc": "0168-0064-15", "marketing_start_date": "19821216"}, {"sample": false, "description": "60 g in 1 TUBE (0168-0064-60)", "package_ndc": "0168-0064-60", "marketing_start_date": "19821216"}], "brand_name": "Fluocinolone Acetonide", "product_id": "0168-0064_2034c4ef-c138-44bd-9101-a7b7660f9d18", "dosage_form": "OINTMENT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0168-0064", "generic_name": "fluocinolone acetonide", "labeler_name": "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluocinolone Acetonide", "active_ingredients": [{"name": "FLUOCINOLONE ACETONIDE", "strength": ".25 mg/g"}], "application_number": "ANDA088168", "marketing_category": "ANDA", "marketing_start_date": "19821216", "listing_expiration_date": "20271231"}