NALOXONE HYDROCHLORIDE

Product NDC
52584-292
11-digit product format
525840292
Labeler code
52584
Product ID
52584-292_9bc48ebc-55d7-4ded-a78d-a3b861b5261b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
naloxone hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
General Injectables & Vaccines, Inc.
Application
ANDA204997
Marketing category
ANDA
Marketing start
2019-12-20
Marketing end
2022-05-31
Substance
NALOXONE HYDROCHLORIDE
Active strength
0 mg/mL
Pharmacologic classes
Opioid Antagonist [EPC],Opioid Antagonists [MoA]
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52584-292-00525840292001 VIAL, SINGLE-DOSE in 1 BAG (52584-292-00) > 1 mL in 1 VIAL, SINGLE-DOSE2019-12-202022-05-31NoNoCurrent