KETAMINE HYDROCHLORIDE

Product NDC
43066-177
11-digit product format
430660177
Labeler code
43066
Product ID
43066-177_549d6ed3-3c9b-4ea2-8aaf-f61d43e04602
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
KETAMINE HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
ANDA219684
Marketing category
ANDA
Marketing start
2025-09-17
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
Rxcui2723913

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
43066-177-01KETAMINE HYDROCHLORIDE1 in 1 CARTONINJECTION14
43066-177-01KETAMINE HYDROCHLORIDE10 mL in 1 SYRINGE, PLASTICINJECTION104
43066-177-05KETAMINE HYDROCHLORIDE5 in 1 CARTONINJECTION54

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2723913ketamine 100 MG in 10 ML Prefilled SyringePSN549d6ed3-3c9b-4ea2-8aaf-f61d43e046024
272391310 ML ketamine 10 MG/ML Prefilled SyringeSCD549d6ed3-3c9b-4ea2-8aaf-f61d43e046024
2723913ketamine 100 MG (as ketamine hydrochloride 115.3 MG) per 10 ML Prefilled SyringeSY549d6ed3-3c9b-4ea2-8aaf-f61d43e046024

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43066-177-01430660177011 in 1 CARTONHistorical
43066-177-05430660177055 CARTON in 1 CARTON (43066-177-05) / 1 SYRINGE, PLASTIC in 1 CARTON (43066-177-01) / 10 mL in 1 SYRINGE, PLASTIC5 carton2025-09-17NoNoHistorical