FDA.reportPublic FDA data

Ketamine Hydrochloride

Product NDC
72572-321
11-digit product format
725720321
Labeler code
72572
Product ID
72572-321_675b63de-32c3-4205-9532-f018e3d3761a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketamine Hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Civica, Inc.
Application
ANDA074524
Marketing category
ANDA
Marketing start
2019-12-05
Substance
KETAMINE HYDROCHLORIDE
Active strength
100 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 HYDROCHLORIDE100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO18YUO0I83
Rxcui238083, 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
72572-321-01Ketamine Hydrochloride5 mL in 1 VIALINJECTION56
72572-321-10Ketamine Hydrochloride10 in 1 BOXINJECTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-321-01ML - Milliliter72572-3219e2a3381-8b56-4b81-9188-4e486bd826ba12020-01-03
72572-321-10ML - Milliliter72572-321fe0e62e6-5097-4c3d-bfbb-a60e41c8cc3f12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-321KETAMINE HYDROCHLORIDE INJECTION [CIVICA, INC.]6Current NDC, Legacy NDC, 2 package rows20240228_58c86d9b-8694-4bd8-8254-f19ee3ad60b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238083ketamine 100 MG/ML Injectable SolutionPSN58c86d9b-8694-4bd8-8254-f19ee3ad60b06
238084ketamine 50 MG/ML Injectable SolutionPSN58c86d9b-8694-4bd8-8254-f19ee3ad60b06
238083ketamine 100 MG/ML Injectable SolutionSCD58c86d9b-8694-4bd8-8254-f19ee3ad60b06
238084ketamine 50 MG/ML Injectable SolutionSCD58c86d9b-8694-4bd8-8254-f19ee3ad60b06
238083ketamine (as ketamine hydrochloride) 100 MG/ML Injectable SolutionSY58c86d9b-8694-4bd8-8254-f19ee3ad60b06
238084ketamine (as ketamine hydrochloride) 50 MG/ML Injectable SolutionSY58c86d9b-8694-4bd8-8254-f19ee3ad60b06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72572-321-01725720321015 mL in 1 VIAL5 mlHistorical
72572-321-107257203211010 VIAL in 1 BOX (72572-321-10) / 5 mL in 1 VIAL (72572-321-01) 10 vial2019-12-050000-00-00NoNoCurrent