Ketamine Hydrochloride

Product NDC
67457-108
11-digit product format
674570108
Labeler code
67457
Product ID
67457-108_76ab136e-3575-42f4-86ea-51e19ec7ab31
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketamine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA076092
Marketing category
ANDA
Marketing start
2013-06-04
Marketing end
0000-00-00
Substance
KETAMINE HYDROCHLORIDE
Active strength
100 mg/mL
Pharmacologic classes
General Anesthesia [PE],General Anesthetic [EPC]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-108-00ML - Milliliter67457-108d8ddd72f-876d-470e-8d26-e2763e5f600112017-03-06
67457-108-10ML - Milliliter67457-1082894d972-32bd-4153-8f56-29e59b264ef712012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-108-106745701081010 VIAL in 1 CARTON (67457-108-10) > 10 mL in 1 VIAL (67457-108-00) 10 vial2013-06-040000-00-00NoNoCurrent