KETAMINE HYDROCHLORIDE

Product NDC
52584-108
11-digit product format
525840108
Labeler code
52584
Product ID
52584-108_db6963dc-47d4-478b-a3c1-84f9b39b8d6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketamine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
General Injectables and Vaccines, Inc.
Application
ANDA076092
Marketing category
ANDA
Marketing start
2018-02-28
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52584-108-002022-12-22C16284748780-1d6a99b39-6a9f-a426-e053-dadaa90af4c2a9f60fc5-1d87-4264-b1a6-4d6722f86e08
52584-108-002022-01-28C16284748780-1d6a99b39-6a9f-a426-e053-dadaa90af4c2a9f60fc5-1d87-4264-b1a6-4d6722f86e08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52584-108-00525840108001 VIAL, MULTI-DOSE in 1 BAG (52584-108-00) > 10 mL in 1 VIAL, MULTI-DOSE2018-02-280000-00-00NoNoCurrent