FDA.reportPublic FDA data

Ketoconazole

Manufacturer
Zydus Lifesciences Limited
Effective date
2025-03-12
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 21:27:28

Label at a glance#

ProductKetoconazole
Active ingredientKETOCONAZOLE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1874-7

Ketoconazole Shampoo, 2%

For Topical Application Only

4 FL OZ (120 mL)

Rx Only

Front Image
Front Image
Back image
Back image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106336ketoconazole 2 % Medicated ShampooPSN2
106336ketoconazole 20 MG/ML Medicated ShampooSCD2
106336ketoconazole 2 % Medicated ShampooSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
KETOCONAZOLE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd9dd88b-5db8-6370-b47e-37f6c9b1c5d5Product name220250331
1e18fb2e-aeff-8efe-93be-5a5f7be8faa2Product name220211209
8bc3781f-20ed-678b-44a7-a981e693c65fProduct name220211209
ff3a8c91-648c-300b-467e-10703f514265Product name220180809
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1874-7Ketoconazole120 mL in 1 BOTTLESHAMPOO1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1874KETOCONAZOLE SHAMPOO [ZYDUS LIFESCIENCES LIMITED]2Current NDC, 1 package rows20250315_c004ee91-558a-450b-9e4e-d11ab9d28054.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-187470771-1874-7

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
KETOCONAZOLER9400W927IACTIB
COCO DIETHANOLAMIDE92005F972DIACT
DISODIUM LAURETH SULFOSUCCINATED6DH1DTN7EIACT
FD&C RED NO. 40WZB9127XOAIACT
HYDROCHLORIC ACIDQTT17582CBIACT
IMIDUREAM629807ATLIACT
PEG-120 METHYL GLUCOSE DIOLEATEYM0K64F20VIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218559-001KETOCONAZOLEKETOCONAZOLE2%SHAMPOO / TOPICALAB2025-03-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A218559-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A218559-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2025-03-0784e616aacf4f…
2026-08-18 06:07:402026-07A218559-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2025-03-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218559-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2025-03-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218559-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2025-03-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A218559-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2025-03-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218559-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2025-03-07fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218559-001KETOCONAZOLE2%SHAMPOO / TOPICALAB2025-03-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A218559-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A218559-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218559-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218559-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218559-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218559-001AB1fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218559-001AB1a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KetoconazoleKETOCONAZOLEZydus Lifesciences Limitedc004ee91-558a-450b-9e4e-d11ab9d280542025-03-12Exact identifier
ndc (package): 70771-1874-7
ndc (product): 70771-1874
ndc11 (package): 70771187407
spl id: 9795147c-bca9-481c-b910-edee5bdd5f29
spl set id: c004ee91-558a-450b-9e4e-d11ab9d28054

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.