KETOTIFEN FUMARATE

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: KETOTIFEN FUMARATE
Generic name: KETOTIFEN FUMARATE
Manufacturer: Unichem Pharmaceuticals (USA), Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 0fe119ad-cb44-4e90-a096-0ed0ba63dc31
SPL ID: 948d4259-9d62-4bc7-9149-6961034364bf
Version: 2
Effective date: 2025-11-24
Source export date: 2026-11-06
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/db89d5ebfc3e02f44e8769334d799cd3436b05f779823ab00297f1f800c89ddf/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:35:37

Harmonized routes table
Harmonized routes
OPHTHALMIC

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	204059	derived:openfda.application_number
application number		ANDA204059	openfda.application_number
brand name		KETOTIFEN FUMARATE	openfda.brand_name
generic name		KETOTIFEN FUMARATE	openfda.generic_name
manufacturer name		Unichem Pharmaceuticals (USA), Inc.	openfda.manufacturer_name
ndc	package	76385-106-17	openfda.package_ndc
ndc	product	76385-106	openfda.product_ndc
ndc11	package	76385010617	derived:openfda.package_ndc
rxcui		311237	openfda.rxcui
spl id		948d4259-9d62-4bc7-9149-6961034364bf	id
spl set id		0fe119ad-cb44-4e90-a096-0ed0ba63dc31	set_id
unii		HBD503WORO	openfda.unii

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