NALOXONE HYDROCHLORIDE

Product NDC
52584-120
11-digit product format
525840120
Labeler code
52584
Product ID
52584-120_ca0a8154-7e84-4bbe-9de9-2cd45acc145b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
naloxone hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
General Injectables and Vaccines, INC.
Application
ANDA207633
Marketing category
ANDA
Marketing start
2021-03-17
Marketing end
2024-03-31
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
52584-120-01525840120011 VIAL, SINGLE-DOSE in 1 BAG (52584-120-01) > 1 mL in 1 VIAL, SINGLE-DOSE2021-03-170000-00-00NoNoCurrent