FDA.reportPublic FDA data

Ketalar

Product NDC
42023-113
11-digit product format
420230113
Labeler code
42023
Product ID
42023-113_00836cdd-f898-4031-85f8-bb58a63b1a9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketamine hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Par Health USA, LLC
Application
NDA016812
Marketing category
NDA
Marketing start
2007-10-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ketalar
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETAMINE HYDROCHLORIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO18YUO0I83
Rxcui206967, 206970, 206972, 238082, 238083, 238084

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bb4bf50b-0475-bcb2-86ff-7b0cc2cc55bcProduct name220240223
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42023-113-10Ketalar20 mL in 1 VIALINJECTION2033
42023-113-10Ketalar10 in 1 CARTONINJECTION1033

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42023-113-10ML - Milliliter42023-11337e2f9c5-a7d3-45c4-bd1b-18da6eba0b5512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ketamine hydrochlorideACTIVE INGREDIENTO18YUO0I83KETALAR (KETAMINE HYDROCHLORIDE) INJECTION [PAR PHARMACEUTICAL, INC.]6
ketamineACTIVE MOIETY690G0D6V8HKETALAR (KETAMINE HYDROCHLORIDE) INJECTION [PAR PHARMACEUTICAL, INC.]6
benzethonium chlorideINACTIVE INGREDIENTPH41D05744KETALAR (KETAMINE HYDROCHLORIDE) INJECTION [PAR PHARMACEUTICAL, INC.]6
sodium chlorideINACTIVE INGREDIENT451W47IQ8XKETALAR (KETAMINE HYDROCHLORIDE) INJECTION [PAR PHARMACEUTICAL, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42023-113KETALAR (KETAMINE HYDROCHLORIDE) INJECTION [ENDO USA, INC.]23Current NDC, Legacy NDC, 2 package rows20240913_14e8f864-8b8a-4e7e-8439-e510d3107063.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
206967Ketalar 10 MG/ML Injectable SolutionPSN14e8f864-8b8a-4e7e-8439-e510d310706333
206970Ketalar 100 MG/ML Injectable SolutionPSN14e8f864-8b8a-4e7e-8439-e510d310706333
206972Ketalar 50 MG/ML Injectable SolutionPSN14e8f864-8b8a-4e7e-8439-e510d310706333
238082ketamine 10 MG/ML Injectable SolutionPSN14e8f864-8b8a-4e7e-8439-e510d310706333
238083ketamine 100 MG/ML Injectable SolutionPSN14e8f864-8b8a-4e7e-8439-e510d310706333
238084ketamine 50 MG/ML Injectable SolutionPSN14e8f864-8b8a-4e7e-8439-e510d310706333
206967ketamine 10 MG/ML Injectable Solution [Ketalar]SBD14e8f864-8b8a-4e7e-8439-e510d310706333
206970ketamine 100 MG/ML Injectable Solution [Ketalar]SBD14e8f864-8b8a-4e7e-8439-e510d310706333
206972ketamine 50 MG/ML Injectable Solution [Ketalar]SBD14e8f864-8b8a-4e7e-8439-e510d310706333
238082ketamine 10 MG/ML Injectable SolutionSCD14e8f864-8b8a-4e7e-8439-e510d310706333
238083ketamine 100 MG/ML Injectable SolutionSCD14e8f864-8b8a-4e7e-8439-e510d310706333
238084ketamine 50 MG/ML Injectable SolutionSCD14e8f864-8b8a-4e7e-8439-e510d310706333
206967Ketalar (ketamine hydrochloride) 10 MG/ML Injectable SolutionSY14e8f864-8b8a-4e7e-8439-e510d310706333
206970Ketalar (ketamine hydrochloride) 100 MG/ML Injectable SolutionSY14e8f864-8b8a-4e7e-8439-e510d310706333
206972Ketalar (ketamine hydrochloride) 50 MG/ML Injectable SolutionSY14e8f864-8b8a-4e7e-8439-e510d310706333
238082ketamine (as ketamine hydrochloride) 10 MG/ML Injectable SolutionSY14e8f864-8b8a-4e7e-8439-e510d310706333
238083ketamine (as ketamine hydrochloride) 100 MG/ML Injectable SolutionSY14e8f864-8b8a-4e7e-8439-e510d310706333
238084ketamine (as ketamine hydrochloride) 50 MG/ML Injectable SolutionSY14e8f864-8b8a-4e7e-8439-e510d310706333
206967Ketalar 10 MG/ML Injectable SolutionPSN46dab560-8ecd-4d92-8c92-6baa2310b09b5
238082ketamine 10 MG/ML Injectable SolutionPSN46dab560-8ecd-4d92-8c92-6baa2310b09b5
206967ketamine 10 MG/ML Injectable Solution [Ketalar]SBD46dab560-8ecd-4d92-8c92-6baa2310b09b5
238082ketamine 10 MG/ML Injectable SolutionSCD46dab560-8ecd-4d92-8c92-6baa2310b09b5
206967Ketalar (ketamine hydrochloride) 10 MG/ML Injectable SolutionSY46dab560-8ecd-4d92-8c92-6baa2310b09b5
238082ketamine (as ketamine hydrochloride) 10 MG/ML Injectable SolutionSY46dab560-8ecd-4d92-8c92-6baa2310b09b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42023-113-104202301131010 VIAL in 1 CARTON (42023-113-10) / 20 mL in 1 VIAL10 vial2007-10-010000-00-00NoNoCurrent