dermotic

Generic: fluocinolone acetonide

Labeler: royal pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

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

fluocinolone acetonide .11 mg/mL

Manufacturer
Royal Pharmaceuticals

Identifiers & Regulatory

Product NDC 68791-103
Product ID 68791-103_195c48d9-bb7a-4c89-b6b8-35fff5aefff8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019452
Listing Expiration 2026-12-31
Marketing Start 2005-11-09

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 68791103
Hyphenated Format 68791-103

Supplemental Identifiers

RxCUI
1191299 1191301
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 dermotic (source: ndc)
Generic Name fluocinolone acetonide (source: ndc)
Application Number NDA019452 (source: ndc)
Routes
AURICULAR (OTIC)
source: ndc

Resolved Composition

Strengths
  • .11 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (68791-103-20) / 20 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

68791-103-20 1 BOTTLE, DROPPER in 1 CARTON (68791-103-20) / 20 mL in 1 BOTTLE, DROPPER

Ingredients (1)

fluocinolone acetonide (.11 mg/mL)

Linked Drug Pages (1)

DERMOTIC ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["AURICULAR (OTIC)"], "spl_id": "195c48d9-bb7a-4c89-b6b8-35fff5aefff8", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["0CD5FD6S2M"], "rxcui": ["1191299", "1191301"], "spl_set_id": ["eb00f222-8105-4e05-90e8-bbd129784364"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Royal Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (68791-103-20)  / 20 mL in 1 BOTTLE, DROPPER", "package_ndc": "68791-103-20", "marketing_start_date": "20051109"}], "brand_name": "DERMOTIC", "product_id": "68791-103_195c48d9-bb7a-4c89-b6b8-35fff5aefff8", "dosage_form": "OIL", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68791-103", "generic_name": "fluocinolone acetonide", "labeler_name": "Royal Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DERMOTIC", "active_ingredients": [{"name": "FLUOCINOLONE ACETONIDE", "strength": ".11 mg/mL"}], "application_number": "NDA019452", "marketing_category": "NDA", "marketing_start_date": "20051109", "listing_expiration_date": "20261231"}