KETALAR

Product NDC
52584-037
11-digit product format
525840037
Labeler code
52584
Product ID
52584-037_705c4709-580e-4f02-8a74-bc9aa0641fe2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketamine hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
General Injectables & Vaccines, Inc
Application
NDA016812
Marketing category
NDA
Marketing start
2012-10-17
Marketing end
2025-02-28
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
0000-00-00
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52584-037-10525840037101 VIAL in 1 BAG (52584-037-10) > 20 mL in 1 VIAL1 vial2012-10-170000-00-00NoNoCurrent