FDA.reportPublic FDA data

Ketamine Hydrochloride

Product NDC
25021-683
11-digit product format
250210683
Labeler code
25021
Product ID
25021-683_51a16c65-47e0-405c-8c84-82a6a28b3efd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketamine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA216809
Marketing category
ANDA
Marketing start
2023-07-15
Substance
KETAMINE HYDROCHLORIDE
Active strength
50 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 HYDROCHLORIDE50 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
25021-683-10Ketamine Hydrochloride10 in 1 CARTONINJECTION, SOLUTION101
25021-683-10Ketamine Hydrochloride10 mL in 1 VIALINJECTION, SOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-683-10ML - Milliliter25021-6831a220a06-5814-464b-83f1-8dc760ba0cf012023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-683KETAMINE HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]1Current NDC, 2 package rows20230715_902c3785-a3cb-472b-ac15-394ac646271d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238082ketamine 10 MG/ML Injectable SolutionPSN902c3785-a3cb-472b-ac15-394ac646271d1
238083ketamine 100 MG/ML Injectable SolutionPSN902c3785-a3cb-472b-ac15-394ac646271d1
238084ketamine 50 MG/ML Injectable SolutionPSN902c3785-a3cb-472b-ac15-394ac646271d1
238082ketamine 10 MG/ML Injectable SolutionSCD902c3785-a3cb-472b-ac15-394ac646271d1
238083ketamine 100 MG/ML Injectable SolutionSCD902c3785-a3cb-472b-ac15-394ac646271d1
238084ketamine 50 MG/ML Injectable SolutionSCD902c3785-a3cb-472b-ac15-394ac646271d1
238082ketamine (as ketamine hydrochloride) 10 MG/ML Injectable SolutionSY902c3785-a3cb-472b-ac15-394ac646271d1
238083ketamine (as ketamine hydrochloride) 100 MG/ML Injectable SolutionSY902c3785-a3cb-472b-ac15-394ac646271d1
238084ketamine (as ketamine hydrochloride) 50 MG/ML Injectable SolutionSY902c3785-a3cb-472b-ac15-394ac646271d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-683-102502106831010 VIAL in 1 CARTON (25021-683-10) / 10 mL in 1 VIAL10 vial2023-07-15NoNoHistorical