fluocinolone acetonide

Generic: fluocinolone acetonide

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

Drug Facts

Product Profile

Brand Name fluocinolone acetonide
Generic Name fluocinolone acetonide
Labeler bryant ranch prepack
Dosage Form OIL
Routes
TOPICAL
Active Ingredients

fluocinolone acetonide .01 mg/100mL

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8655
Product ID 63629-8655_d426f300-cd7e-4356-9d1c-8738ceb1fba9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202847
Listing Expiration 2026-12-31
Marketing Start 2017-06-14

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 636298655
Hyphenated Format 63629-8655

Supplemental Identifiers

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 (source: ndc)
Generic Name fluocinolone acetonide (source: ndc)
Application Number ANDA202847 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .01 mg/100mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (63629-8655-1) / 118.28 mL in 1 BOTTLE
source: ndc

Packages (1)

63629-8655-1 1 BOTTLE in 1 CARTON (63629-8655-1) / 118.28 mL in 1 BOTTLE

Ingredients (1)

fluocinolone acetonide (.01 mg/100mL)

Linked Drug Pages (1)

fluocinolone acetonide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "d426f300-cd7e-4356-9d1c-8738ceb1fba9", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["0CD5FD6S2M"], "spl_set_id": ["71541422-f12c-4e92-8012-dba59112070c"], "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 (63629-8655-1)  / 118.28 mL in 1 BOTTLE", "package_ndc": "63629-8655-1", "marketing_start_date": "20170614"}], "brand_name": "fluocinolone acetonide", "product_id": "63629-8655_d426f300-cd7e-4356-9d1c-8738ceb1fba9", "dosage_form": "OIL", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "63629-8655", "generic_name": "fluocinolone acetonide", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "fluocinolone acetonide", "active_ingredients": [{"name": "FLUOCINOLONE ACETONIDE", "strength": ".01 mg/100mL"}], "application_number": "ANDA202847", "marketing_category": "ANDA", "marketing_start_date": "20170614", "listing_expiration_date": "20261231"}