FDA.reportPublic FDA data

NDC 69043-063 - 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
69043-063
Package NDCs from labels
69043-063-01
Manufacturer
Cronus Pharma LLC
Effective date
2026-03-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ketamine Hydrochloride Injection - Cronus Pharma LLCCronus Pharma LLC2026-03-10PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69043-063-01Ketamine Hydrochloride1 in 1 CARTONINJECTION12
69043-063-01Ketamine Hydrochloride10 mL in 1 VIAL, GLASSINJECTION102

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 ยท 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KETAMINE HYDROCHLORIDEKETAMINE HYDROCHLORIDEHenry Schein, Inc.76d6aad3-0515-49da-a6e1-3fe2a1938a242026-09-08Warnings, Adverse reactionsExact identifier
rxcui: 238083
unii: O18YUO0I83
Ketamine HydrochlorideKETAMINE HYDROCHLORIDECivica, Inc.58c86d9b-8694-4bd8-8254-f19ee3ad60b02026-06-09Warnings, Adverse reactionsExact identifier
rxcui: 238083
unii: O18YUO0I83
Ketamine HydrochlorideKETAMINE HYDROCHLORIDEHospira, Inc.bb912318-2e22-4469-b0a2-774803ee1bb82026-05-12Warnings, Adverse reactionsExact identifier
rxcui: 238083
unii: O18YUO0I83
Ketamine HydrochlorideKETAMINE HYDROCHLORIDEGland Pharma Limitedb96a0a23-3ca0-4a92-bd8b-1e99219317722026-04-16Warnings, Adverse reactionsExact identifier
rxcui: 238083
unii: O18YUO0I83
KetalarKETAMINE HYDROCHLORIDEPar Health USA, LLC14e8f864-8b8a-4e7e-8439-e510d31070632026-03-27Warnings, Adverse reactionsExact identifier
rxcui: 238083
unii: O18YUO0I83
ketamine hydrochlorideKETAMINE HYDROCHLORIDEFresenius Kabi USA, LLCac2e715d-251c-4e3f-b91c-972f466d0beb2025-10-03Warnings, Adverse reactionsExact identifier
rxcui: 238083
unii: O18YUO0I83
KETAMINE HYDROCHLORIDEKETAMINE HYDROCHLORIDEBaxter Healthcare Corporation549d6ed3-3c9b-4ea2-8aaf-f61d43e046022025-06-26Warnings, Adverse reactionsExact identifier
unii: O18YUO0I83
ketamine hydrochlorideKETAMINE HYDROCHLORIDEFresenius Kabi USA, LLCcc67b0fd-ca73-49f6-b5ca-705dc73317762025-04-23Warnings, Adverse reactionsExact identifier
rxcui: 238083
unii: O18YUO0I83
KETALARKETAMINE HYDROCHLORIDEHenry Schein, Inc46dab560-8ecd-4d92-8c92-6baa2310b09b2025-01-27Warnings, Adverse reactionsExact identifier
unii: O18YUO0I83
Ketamine HydrochlorideKETAMINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.58487c78-a641-4278-acc0-343596ee86832024-02-26Warnings, Adverse reactionsExact identifier
rxcui: 238083
unii: O18YUO0I83
Ketamine HydrochlorideKETAMINE HYDROCHLORIDESagent Pharmaceuticals902c3785-a3cb-472b-ac15-394ac646271d2023-05-01Warnings, Adverse reactionsExact identifier
rxcui: 238083
unii: O18YUO0I83
Ketamine HydrochlorideKETAMINE HYDROCHLORIDEMedical Purchasing Solutions, LLCc8e90cec-621e-f8d8-e053-2a95a90a49d42023-04-27Warnings, Adverse reactionsExact identifier
rxcui: 238083
unii: O18YUO0I83
Ketamine HydrochlorideKETAMINE HYDROCHLORIDEMedical Purchasing Solutions, LLCea600f8a-857f-4e0e-e053-2995a90a017d2023-04-24Warnings, Adverse reactionsExact identifier
rxcui: 238083
unii: O18YUO0I83

Reported adverse events (FAERS/openFDA)#

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