fluocinolone acetonide topical (0591-2990)

Drug Facts

Product Profile

Brand Name fluocinolone acetonide topical

Generic Name fluocinolone acetonide topical

Labeler actavis pharma, inc.

Dosage Form SOLUTION

Routes

TOPICAL

Active Ingredients

fluocinolone acetonide .1 mg/mL

Manufacturer

Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-2990

Product ID 0591-2990_8c1b96a1-47e6-4fac-9bda-0b299ac25800

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA208386

Listing Expiration 2026-12-31

Marketing Start 2016-12-07

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 05912990

Hyphenated Format 0591-2990

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 topical (source: ndc)

Generic Name fluocinolone acetonide topical (source: ndc)

Application Number ANDA208386 (source: ndc)

Routes

TOPICAL

source: ndc

Resolved Composition

Strengths

.1 mg/mL

source: ndc

Packaging

1 BOTTLE, WITH APPLICATOR in 1 CARTON (0591-2990-60) / 60 mL in 1 BOTTLE, WITH APPLICATOR

source: ndc

Packages (1)

0591-2990-60 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0591-2990-60) / 60 mL in 1 BOTTLE, WITH APPLICATOR

Ingredients (1)

fluocinolone acetonide (.1 mg/mL)

Linked Drug Pages (1)

Fluocinolone Acetonide Topical ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["TOPICAL"], "spl_id": "8c1b96a1-47e6-4fac-9bda-0b299ac25800", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["0CD5FD6S2M"], "rxcui": ["1191310"], "spl_set_id": ["98dfd7a4-2208-4637-acf5-080a5813a433"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (0591-2990-60)  / 60 mL in 1 BOTTLE, WITH APPLICATOR", "package_ndc": "0591-2990-60", "marketing_start_date": "20161207"}], "brand_name": "Fluocinolone Acetonide Topical", "product_id": "0591-2990_8c1b96a1-47e6-4fac-9bda-0b299ac25800", "dosage_form": "SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0591-2990", "generic_name": "Fluocinolone Acetonide Topical", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluocinolone Acetonide Topical", "active_ingredients": [{"name": "FLUOCINOLONE ACETONIDE", "strength": ".1 mg/mL"}], "application_number": "ANDA208386", "marketing_category": "ANDA", "marketing_start_date": "20161207", "listing_expiration_date": "20261231"}