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 OIL
Routes
TOPICAL
Active Ingredients

fluocinolone acetonide .11 mg/118.28mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-1357
Product ID 51672-1357_3dd48727-c9ec-69b5-e063-6294a90a3c31
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209336
Listing Expiration 2026-12-31
Marketing Start 2016-05-19

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 516721357
Hyphenated Format 51672-1357

Supplemental Identifiers

UPC
0351672135782
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 ANDA209336 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .11 mg/118.28mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (51672-1357-8) / 118.28 mL in 1 BOTTLE
source: ndc

Packages (1)

51672-1357-8 1 BOTTLE in 1 CARTON (51672-1357-8) / 118.28 mL in 1 BOTTLE

Ingredients (1)

fluocinolone acetonide (.11 mg/118.28mL)

Linked Drug Pages (1)

Fluocinolone Acetonide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3dd48727-c9ec-69b5-e063-6294a90a3c31", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0351672135782"], "unii": ["0CD5FD6S2M"], "spl_set_id": ["b6796a10-9c90-429d-bfd6-33b557dc952c"], "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 (51672-1357-8)  / 118.28 mL in 1 BOTTLE", "package_ndc": "51672-1357-8", "marketing_start_date": "20160519"}], "brand_name": "Fluocinolone Acetonide", "product_id": "51672-1357_3dd48727-c9ec-69b5-e063-6294a90a3c31", "dosage_form": "OIL", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "51672-1357", "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": ".11 mg/118.28mL"}], "application_number": "ANDA209336", "marketing_category": "ANDA", "marketing_start_date": "20160519", "listing_expiration_date": "20261231"}