FDA.reportPublic FDA data

Ketamine Hydrochloride

Product NDC
68083-504
11-digit product format
680830504
Labeler code
68083
Product ID
68083-504_142e6bdd-dd6a-4aba-ab22-5bf1a9423211
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketamine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA216809
Marketing category
ANDA
Marketing start
2023-01-24
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
Ketamine Hydrochloride
Listing expiration
2027-12-31

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
68083-504-10Ketamine Hydrochloride10 in 1 CARTONINJECTION, SOLUTION106
68083-504-10Ketamine Hydrochloride20 mL in 1 VIALINJECTION, SOLUTION206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-504KETAMINE HYDROCHLORIDE INJECTION, SOLUTION [GLAND PHARMA LIMITED]4Current NDC, 2 package rows20230225_b96a0a23-3ca0-4a92-bd8b-1e9921931772.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238082ketamine 10 MG/ML Injectable SolutionPSNb96a0a23-3ca0-4a92-bd8b-1e99219317726
238083ketamine 100 MG/ML Injectable SolutionPSNb96a0a23-3ca0-4a92-bd8b-1e99219317726
238084ketamine 50 MG/ML Injectable SolutionPSNb96a0a23-3ca0-4a92-bd8b-1e99219317726
238082ketamine 10 MG/ML Injectable SolutionSCDb96a0a23-3ca0-4a92-bd8b-1e99219317726
238083ketamine 100 MG/ML Injectable SolutionSCDb96a0a23-3ca0-4a92-bd8b-1e99219317726
238084ketamine 50 MG/ML Injectable SolutionSCDb96a0a23-3ca0-4a92-bd8b-1e99219317726
238082ketamine (as ketamine hydrochloride) 10 MG/ML Injectable SolutionSYb96a0a23-3ca0-4a92-bd8b-1e99219317726
238083ketamine (as ketamine hydrochloride) 100 MG/ML Injectable SolutionSYb96a0a23-3ca0-4a92-bd8b-1e99219317726
238084ketamine (as ketamine hydrochloride) 50 MG/ML Injectable SolutionSYb96a0a23-3ca0-4a92-bd8b-1e99219317726

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68083-504-106808305041010 VIAL in 1 CARTON (68083-504-10) / 20 mL in 1 VIAL10 vial2023-01-24NoNoCurrent