fluocinonide

Generic: fluocinonide

Labeler: lupin pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluocinonide
Generic Name fluocinonide
Labeler lupin pharmaceuticals,inc.
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

fluocinonide .5 mg/mL

Manufacturer
Lupin Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 43386-026
Product ID 43386-026_465101b9-6374-4ce8-b64d-97e296f5c72a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206003
Listing Expiration 2026-12-31
Marketing Start 2017-07-21

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 43386026
Hyphenated Format 43386-026

Supplemental Identifiers

RxCUI
310364
UNII
2W4A77YPAN
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 fluocinonide (source: ndc)
Generic Name fluocinonide (source: ndc)
Application Number ANDA206003 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (43386-026-02) / 20 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (43386-026-06) / 60 mL in 1 BOTTLE
source: ndc

Packages (2)

43386-026-02 1 BOTTLE in 1 CARTON (43386-026-02) / 20 mL in 1 BOTTLE 43386-026-06 1 BOTTLE in 1 CARTON (43386-026-06) / 60 mL in 1 BOTTLE

Ingredients (1)

fluocinonide (.5 mg/mL)

Linked Drug Pages (1)

Fluocinonide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "465101b9-6374-4ce8-b64d-97e296f5c72a", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["2W4A77YPAN"], "rxcui": ["310364"], "spl_set_id": ["43b7621c-6628-4b54-af32-32efd0f722da"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Lupin Pharmaceuticals,Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (43386-026-02)  / 20 mL in 1 BOTTLE", "package_ndc": "43386-026-02", "marketing_start_date": "20170721"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (43386-026-06)  / 60 mL in 1 BOTTLE", "package_ndc": "43386-026-06", "marketing_start_date": "20170721"}], "brand_name": "Fluocinonide", "product_id": "43386-026_465101b9-6374-4ce8-b64d-97e296f5c72a", "dosage_form": "SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "43386-026", "generic_name": "Fluocinonide", "labeler_name": "Lupin Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluocinonide", "active_ingredients": [{"name": "FLUOCINONIDE", "strength": ".5 mg/mL"}], "application_number": "ANDA206003", "marketing_category": "ANDA", "marketing_start_date": "20170721", "listing_expiration_date": "20261231"}