fluocinolone acetonide

Generic: fluocinolone acetonide

Labeler: quagen pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluocinolone acetonide
Generic Name fluocinolone acetonide
Labeler quagen pharmaceuticals llc
Dosage Form OIL
Routes
AURICULAR (OTIC)
Active Ingredients

fluocinolone acetonide .11 mg/mL

Manufacturer
Quagen Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 70752-159
Product ID 70752-159_c2b257ee-da2e-4af6-908a-aeb4838e698e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212762
Listing Expiration 2026-12-31
Marketing Start 2021-04-02

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 70752159
Hyphenated Format 70752-159

Supplemental Identifiers

RxCUI
1191299
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 ANDA212762 (source: ndc)
Routes
AURICULAR (OTIC)
source: ndc

Resolved Composition

Strengths
  • .11 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70752-159-20) / 20 mL in 1 BOTTLE
source: ndc

Packages (1)

70752-159-20 1 BOTTLE in 1 CARTON (70752-159-20) / 20 mL in 1 BOTTLE

Ingredients (1)

fluocinolone acetonide (.11 mg/mL)

Linked Drug Pages (1)

FLUOCINOLONE ACETONIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["AURICULAR (OTIC)"], "spl_id": "c2b257ee-da2e-4af6-908a-aeb4838e698e", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["0CD5FD6S2M"], "rxcui": ["1191299"], "spl_set_id": ["2bcea813-d629-42c5-8953-fa231b4cbf58"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Quagen Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70752-159-20)  / 20 mL in 1 BOTTLE", "package_ndc": "70752-159-20", "marketing_start_date": "20210402"}], "brand_name": "FLUOCINOLONE ACETONIDE", "product_id": "70752-159_c2b257ee-da2e-4af6-908a-aeb4838e698e", "dosage_form": "OIL", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "70752-159", "generic_name": "fluocinolone acetonide", "labeler_name": "Quagen Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FLUOCINOLONE ACETONIDE", "active_ingredients": [{"name": "FLUOCINOLONE ACETONIDE", "strength": ".11 mg/mL"}], "application_number": "ANDA212762", "marketing_category": "ANDA", "marketing_start_date": "20210402", "listing_expiration_date": "20261231"}