FDA.reportPublic FDA data

ketamine hydrochloride

Product NDC
65219-184
11-digit product format
652190184
Labeler code
65219
Product ID
65219-184_9acdebb0-6e88-42b2-ac45-da51aaad0f3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketamine hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA215808
Marketing category
ANDA
Marketing start
2023-07-10
Substance
KETAMINE HYDROCHLORIDE
Active strength
10 mg/mL
Pharmacologic classes
General Anesthesia [PE], General Anesthetic [EPC]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ketamine hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETAMINE HYDROCHLORIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO18YUO0I83
Rxcui238082, 238083, 238084

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bb4bf50b-0475-bcb2-86ff-7b0cc2cc55bcProduct name220240223

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-184-01ketamine hydrochloride20 mL in 1 VIALINJECTION202
65219-184-20ketamine hydrochloride10 in 1 TRAYINJECTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-184-01ML - Milliliter65219-18494c30077-2f32-4736-bb95-90000d5e77d812024-04-05
65219-184-20ML - Milliliter65219-184b1c0b3c2-9ecd-4d58-b8cb-d592c956070812024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-184KETAMINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC ]2Current NDC, 2 package rows20250427_cc67b0fd-ca73-49f6-b5ca-705dc7331776.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238082ketamine 10 MG/ML Injectable SolutionPSNcc67b0fd-ca73-49f6-b5ca-705dc73317762
238083ketamine 100 MG/ML Injectable SolutionPSNcc67b0fd-ca73-49f6-b5ca-705dc73317762
238084ketamine 50 MG/ML Injectable SolutionPSNcc67b0fd-ca73-49f6-b5ca-705dc73317762
238082ketamine 10 MG/ML Injectable SolutionSCDcc67b0fd-ca73-49f6-b5ca-705dc73317762
238083ketamine 100 MG/ML Injectable SolutionSCDcc67b0fd-ca73-49f6-b5ca-705dc73317762
238084ketamine 50 MG/ML Injectable SolutionSCDcc67b0fd-ca73-49f6-b5ca-705dc73317762
238082ketamine (as ketamine hydrochloride) 10 MG/ML Injectable SolutionSYcc67b0fd-ca73-49f6-b5ca-705dc73317762
238083ketamine (as ketamine hydrochloride) 100 MG/ML Injectable SolutionSYcc67b0fd-ca73-49f6-b5ca-705dc73317762
238084ketamine (as ketamine hydrochloride) 50 MG/ML Injectable SolutionSYcc67b0fd-ca73-49f6-b5ca-705dc73317762

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65219-184-016521901840120 mL in 1 VIAL20 mlHistorical
65219-184-206521901842010 VIAL in 1 TRAY (65219-184-20) / 20 mL in 1 VIAL (65219-184-01) 10 vial2023-07-10NoNoHistorical