Ketoconazole

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: Ketoconazole
Generic name: KETOCONAZOLE
Manufacturer: Zydus Lifesciences Limited
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: c004ee91-558a-450b-9e4e-d11ab9d28054
SPL ID: 9795147c-bca9-481c-b910-edee5bdd5f29
Version: 2
Effective date: 2025-03-12
Source export date: 2026-10-27
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/977776a6cc37ec1c77259da8a93ae161850a3aa120341096e5a03428b84d016b/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:57:49

Harmonized routes table
Harmonized routes
TOPICAL

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	218559	derived:openfda.application_number
application number		ANDA218559	openfda.application_number
brand name		Ketoconazole	openfda.brand_name
generic name		KETOCONAZOLE	openfda.generic_name
manufacturer name		Zydus Lifesciences Limited	openfda.manufacturer_name
ndc	package	70771-1874-7	openfda.package_ndc
ndc	product	70771-1874	openfda.product_ndc
ndc11	package	70771187407	derived:openfda.package_ndc
rxcui		106336	openfda.rxcui
spl id		9795147c-bca9-481c-b910-edee5bdd5f29	id
spl set id		c004ee91-558a-450b-9e4e-d11ab9d28054	set_id
unii		R9400W927I	openfda.unii

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