fluocinolone acetonide

Generic: fluocinolone acetonide

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

Drug Facts

Product Profile

Brand Name fluocinolone acetonide
Generic Name fluocinolone acetonide
Labeler glenmark pharmaceuticals inc., usa
Dosage Form OIL
Routes
AURICULAR (OTIC)
Active Ingredients

fluocinolone acetonide .11 mg/mL

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-185
Product ID 68462-185_cc1f615e-6cb2-4721-84c6-e5f170b64d90
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211815
Listing Expiration 2026-12-31
Marketing Start 2018-12-18

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 68462185
Hyphenated Format 68462-185

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 ANDA211815 (source: ndc)
Routes
AURICULAR (OTIC)
source: ndc

Resolved Composition

Strengths
  • .11 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (68462-185-56) / 20 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

68462-185-56 1 BOTTLE, DROPPER in 1 CARTON (68462-185-56) / 20 mL in 1 BOTTLE, DROPPER

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": "cc1f615e-6cb2-4721-84c6-e5f170b64d90", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["0CD5FD6S2M"], "rxcui": ["1191299"], "spl_set_id": ["a00224b0-3db5-4d40-b370-5ec5476e1e10"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (68462-185-56)  / 20 mL in 1 BOTTLE, DROPPER", "package_ndc": "68462-185-56", "marketing_start_date": "20181218"}], "brand_name": "fluocinolone acetonide", "product_id": "68462-185_cc1f615e-6cb2-4721-84c6-e5f170b64d90", "dosage_form": "OIL", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68462-185", "generic_name": "fluocinolone acetonide", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "fluocinolone acetonide", "active_ingredients": [{"name": "FLUOCINOLONE ACETONIDE", "strength": ".11 mg/mL"}], "application_number": "ANDA211815", "marketing_category": "ANDA", "marketing_start_date": "20181218", "listing_expiration_date": "20261231"}