fluocinolone acetonide oil

Generic: fluocinolone acetonide

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

Drug Facts

Product Profile

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

fluocinolone acetonide .11 mg/mL

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-329
Product ID 64980-329_4e01be19-15cd-4b8f-bbae-158c27b556f3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203378
Listing Expiration 2027-12-31
Marketing Start 2016-09-14

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 64980329
Hyphenated Format 64980-329

Supplemental Identifiers

UPC
0364980329200
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 oil (source: ndc)
Generic Name fluocinolone acetonide (source: ndc)
Application Number ANDA203378 (source: ndc)
Routes
AURICULAR (OTIC)
source: ndc

Resolved Composition

Strengths
  • .11 mg/mL
source: ndc
Packaging
  • 20 mL in 1 BOTTLE (64980-329-20)
source: ndc

Packages (1)

64980-329-20 20 mL in 1 BOTTLE (64980-329-20)

Ingredients (1)

fluocinolone acetonide (.11 mg/mL)

Linked Drug Pages (1)

Fluocinolone Acetonide Oil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["AURICULAR (OTIC)"], "spl_id": "4e01be19-15cd-4b8f-bbae-158c27b556f3", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0364980329200"], "unii": ["0CD5FD6S2M"], "spl_set_id": ["79591576-1eab-48c5-b0a6-e205b3cc097e"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 mL in 1 BOTTLE (64980-329-20)", "package_ndc": "64980-329-20", "marketing_start_date": "20160914"}], "brand_name": "Fluocinolone Acetonide Oil", "product_id": "64980-329_4e01be19-15cd-4b8f-bbae-158c27b556f3", "dosage_form": "OIL", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "64980-329", "generic_name": "Fluocinolone Acetonide", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluocinolone Acetonide", "brand_name_suffix": "Oil", "active_ingredients": [{"name": "FLUOCINOLONE ACETONIDE", "strength": ".11 mg/mL"}], "application_number": "ANDA203378", "marketing_category": "ANDA", "marketing_start_date": "20160914", "listing_expiration_date": "20271231"}