flac otic oil

Generic: fluocinolone acetonide

Labeler: patrin pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name flac otic oil
Generic Name fluocinolone acetonide
Labeler patrin pharma, inc.
Dosage Form OIL
Routes
AURICULAR (OTIC)
Active Ingredients

fluocinolone acetonide .11 mg/mL

Manufacturer
Patrin Pharma, Inc.

Identifiers & Regulatory

Product NDC 39328-079
Product ID 39328-079_b9a91a1b-2c51-4ef3-8152-7a720061b5aa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210736
Listing Expiration 2026-12-31
Marketing Start 2018-04-12

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 39328079
Hyphenated Format 39328-079

Supplemental Identifiers

RxCUI
1191299 2045201
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 flac otic oil (source: ndc)
Generic Name fluocinolone acetonide (source: ndc)
Application Number ANDA210736 (source: ndc)
Routes
AURICULAR (OTIC)
source: ndc

Resolved Composition

Strengths
  • .11 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (39328-079-20) / 20 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

39328-079-20 1 BOTTLE, DROPPER in 1 CARTON (39328-079-20) / 20 mL in 1 BOTTLE, DROPPER

Ingredients (1)

fluocinolone acetonide (.11 mg/mL)

Linked Drug Pages (1)

Flac Otic Oil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["AURICULAR (OTIC)"], "spl_id": "b9a91a1b-2c51-4ef3-8152-7a720061b5aa", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["0CD5FD6S2M"], "rxcui": ["1191299", "2045201"], "spl_set_id": ["4b0a46b6-dcb7-4c4e-8b02-cf72eede3cbb"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Patrin Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (39328-079-20)  / 20 mL in 1 BOTTLE, DROPPER", "package_ndc": "39328-079-20", "marketing_start_date": "20180412"}], "brand_name": "Flac Otic Oil", "product_id": "39328-079_b9a91a1b-2c51-4ef3-8152-7a720061b5aa", "dosage_form": "OIL", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "39328-079", "generic_name": "fluocinolone acetonide", "labeler_name": "Patrin Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Flac Otic Oil", "active_ingredients": [{"name": "FLUOCINOLONE ACETONIDE", "strength": ".11 mg/mL"}], "application_number": "ANDA210736", "marketing_category": "ANDA", "marketing_start_date": "20180412", "listing_expiration_date": "20261231"}