fluocinolone acetonide

Generic: fluocinolone acetonide

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name fluocinolone acetonide
Generic Name fluocinolone acetonide
Labeler ani pharmaceuticals, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

fluocinolone acetonide .25 mg/g

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 62559-289
Product ID 62559-289_9a3159b1-5a5c-4784-8f61-a132de5c4608
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA012787
Listing Expiration 2027-12-31
Marketing Start 2024-05-08

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 62559289
Hyphenated Format 62559-289

Supplemental Identifiers

RxCUI
1191302 1191315
UPC
0362559288156 0362559289153
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 NDA012787 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .25 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (62559-289-15) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (62559-289-60) / 60 g in 1 TUBE
source: ndc

Packages (2)

62559-289-15 1 TUBE in 1 CARTON (62559-289-15) / 15 g in 1 TUBE 62559-289-60 1 TUBE in 1 CARTON (62559-289-60) / 60 g in 1 TUBE

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": "9a3159b1-5a5c-4784-8f61-a132de5c4608", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0362559288156", "0362559289153"], "unii": ["0CD5FD6S2M"], "rxcui": ["1191302", "1191315"], "spl_set_id": ["50e7006d-a51b-49aa-8e1c-330340e7bf82"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (62559-289-15)  / 15 g in 1 TUBE", "package_ndc": "62559-289-15", "marketing_start_date": "20240508"}, {"sample": false, "description": "1 TUBE in 1 CARTON (62559-289-60)  / 60 g in 1 TUBE", "package_ndc": "62559-289-60", "marketing_start_date": "20240508"}], "brand_name": "fluocinolone acetonide", "product_id": "62559-289_9a3159b1-5a5c-4784-8f61-a132de5c4608", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "62559-289", "generic_name": "fluocinolone acetonide", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "fluocinolone acetonide", "active_ingredients": [{"name": "FLUOCINOLONE ACETONIDE", "strength": ".25 mg/g"}], "application_number": "NDA012787", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20240508", "listing_expiration_date": "20271231"}