NALOXONE HYDROCHLORIDE

Product NDC
63629-9321
11-digit product format
636299321
Labeler code
63629
Product ID
63629-9321_9c47fac5-40e9-43ae-b7d1-9a12ad1f8b3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
naloxone hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Bryant Ranch Prepack
Application
ANDA211951
Marketing category
ANDA
Marketing start
2022-06-21
Marketing end
0000-00-00
Substance
NALOXONE HYDROCHLORIDE
Active strength
4 mg/.1mL
Pharmacologic classes
Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9321NALOXONE HYDROCHLORIDE SPRAY [BRYANT RANCH PREPACK]102Legacy NDC20240116_73edcc70-d988-4f66-a09a-8d23042283c3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9321-1636299321012 mL in 1 VIAL, SINGLE-DOSE (63629-9321-1) 2 ml2022-07-070000-00-00NoNoCurrent