fluocinolone acetonide

Generic: fluocinolone acetonide

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

Drug Facts

Product Profile

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

fluocinolone acetonide .1 mg/mL

Manufacturer
Lupin Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 43386-069
Product ID 43386-069_15764733-88e0-40bf-ac92-ff4e3e35b15d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206422
Listing Expiration 2026-12-31
Marketing Start 2015-09-02

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 43386069
Hyphenated Format 43386-069

Supplemental Identifiers

RxCUI
1191310
UPC
0343386069606
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 ANDA206422 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (43386-069-60) / 60 mL in 1 BOTTLE
source: ndc

Packages (1)

43386-069-60 1 BOTTLE in 1 CARTON (43386-069-60) / 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": "15764733-88e0-40bf-ac92-ff4e3e35b15d", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0343386069606"], "unii": ["0CD5FD6S2M"], "rxcui": ["1191310"], "spl_set_id": ["460f5a55-6437-4651-bc08-8063ca579c8d"], "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 (43386-069-60)  / 60 mL in 1 BOTTLE", "package_ndc": "43386-069-60", "marketing_start_date": "20150902"}], "brand_name": "Fluocinolone Acetonide", "product_id": "43386-069_15764733-88e0-40bf-ac92-ff4e3e35b15d", "dosage_form": "SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "43386-069", "generic_name": "Fluocinolone Acetonide", "labeler_name": "Lupin Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluocinolone Acetonide", "active_ingredients": [{"name": "FLUOCINOLONE ACETONIDE", "strength": ".1 mg/mL"}], "application_number": "ANDA206422", "marketing_category": "ANDA", "marketing_start_date": "20150902", "listing_expiration_date": "20261231"}