fluocinolone acetonide

Generic: fluocinolone acetonide

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluocinolone acetonide
Generic Name fluocinolone acetonide
Labeler sun pharmaceutical industries, inc.
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

fluocinolone acetonide .1 mg/mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-1365
Product ID 51672-1365_390af125-04e3-1010-e063-6294a90a016d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA089124
Listing Expiration 2026-12-31
Marketing Start 2015-03-27

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 516721365
Hyphenated Format 51672-1365

Supplemental Identifiers

RxCUI
1191310
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 ANDA089124 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (51672-1365-2) / 20 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (51672-1365-4) / 60 mL in 1 BOTTLE
source: ndc

Packages (2)

51672-1365-2 1 BOTTLE in 1 CARTON (51672-1365-2) / 20 mL in 1 BOTTLE 51672-1365-4 1 BOTTLE in 1 CARTON (51672-1365-4) / 60 mL in 1 BOTTLE

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": "390af125-04e3-1010-e063-6294a90a016d", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["0CD5FD6S2M"], "rxcui": ["1191310"], "spl_set_id": ["02352ed1-3568-441f-add8-45201351a11c"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (51672-1365-2)  / 20 mL in 1 BOTTLE", "package_ndc": "51672-1365-2", "marketing_start_date": "20150327"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (51672-1365-4)  / 60 mL in 1 BOTTLE", "package_ndc": "51672-1365-4", "marketing_start_date": "20150327"}], "brand_name": "Fluocinolone Acetonide", "product_id": "51672-1365_390af125-04e3-1010-e063-6294a90a016d", "dosage_form": "SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "51672-1365", "generic_name": "fluocinolone acetonide", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluocinolone Acetonide", "active_ingredients": [{"name": "FLUOCINOLONE ACETONIDE", "strength": ".1 mg/mL"}], "application_number": "ANDA089124", "marketing_category": "ANDA", "marketing_start_date": "20150327", "listing_expiration_date": "20261231"}