NALOXONE HYDROCHLORIDE

Product NDC
52584-058
11-digit product format
525840058
Labeler code
52584
Product ID
52584-058_9168d80f-6ee7-4792-a184-4fb377acf8bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NALOXONE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
General Injectables and Vaccines, Inc.
Application
ANDA208871
Marketing category
ANDA
Marketing start
2018-06-12
Marketing end
2021-04-30
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
52584-058-01525840058011 VIAL, SINGLE-DOSE in 1 BAG (52584-058-01) > 1 mL in 1 VIAL, SINGLE-DOSE2018-06-122021-04-30NoNoCurrent