FDA.reportPublic FDA data

NDC 0143-9508-01 - Ketamine Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0143-9508
Requested NDC
0143-9508-01
Package NDCs from labels
0143-9508-01, 0143-9508-10
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2024-02-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ketamine Hydrochloride - Hikma Pharmaceuticals USA Inc.Hikma Pharmaceuticals USA Inc.2024-02-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9508-01Ketamine Hydrochloride10 mL in 1 VIALINJECTION108
0143-9508-10Ketamine Hydrochloride10 in 1 BOXINJECTION108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9508KETAMINE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]8Current NDC, Legacy NDC, 2 package rows20240228_58487c78-a641-4278-acc0-343596ee8683.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9508-01ML - Milliliter0143-9508a20dceef-c8dd-42e8-b70f-41e2156fbcf012017-03-06
0143-9508-10ML - Milliliter0143-9508cd6cd94b-5e79-40aa-961a-f6a09618d8f712017-03-06

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 7 of 7 · 126 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ketamine HydrochlorideKETAMINE HYDROCHLORIDEMedical Purchasing Solutions, LLCc8e90cec-621e-f8d8-e053-2a95a90a49d42023-04-27Warnings, Adverse reactionsExact identifier
application number: ANDA074524
rxcui: 238083
unii: O18YUO0I83
Ketamine HydrochlorideKETAMINE HYDROCHLORIDEMedical Purchasing Solutions, LLCea600f8a-857f-4e0e-e053-2995a90a017d2023-04-24Warnings, Adverse reactionsExact identifier
rxcui: 238083
unii: O18YUO0I83
ZylastXP Antiseptic FoamingBENZETHONIUM CHLORIDEInnovative Biodefense86857d95-56ce-2eb4-e053-2a91aa0ad5572023-01-01WarningsExact identifier
unii: PH41D05744
ANTIMICROBIAL FACE BODY WASHBENZETHONIUM CHLORIDE LIQUIDBio-Medical & Pharmaceutical Manufacturing Corporation210dc091-4a9b-0c48-e054-00144ff88e882020-04-15WarningsExact identifier
unii: PH41D05744
CPAP Mask cleaning wipesBENZETHONIUM CHLORIDE AND BENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.412e6fec-5af5-45f7-8c6b-393b884e161c2019-06-07WarningsExact identifier
unii: PH41D05744
Hand WipesCHLORHEXIDINE DIGLUCONATE AND BENZETHONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.181e5fa0-ddda-4783-a0b5-ff95bfce6b362017-10-09WarningsExact identifier
unii: PH41D05744

Reported adverse events (FAERS/openFDA)#

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