NALOXONE HYDROCHLORIDE

Product NDC
0404-9921
11-digit product format
004049921
Labeler code
0404
Product ID
0404-9921_ff9e1ff6-2dd5-4b2f-83ca-a98fda92f01b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
naloxone hydrochloride
Dosage form
INJECTION
Route
PARENTERAL
Labeler
Henry Schein, Inc.
Application
ANDA072076
Marketing category
ANDA
Marketing start
2022-01-18
Marketing end
0000-00-00
Substance
NALOXONE HYDROCHLORIDE
Active strength
1 mg/mL
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
0404-9921NALOXONE HYDROCHLORIDE INJECTION [HENRY SCHEIN, INC.]5Legacy NDC20241105_6d8e0730-f224-4186-9927-6acce7d3392b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0404-9921-02004049921021 BOX in 1 BAG (0404-9921-02) > 1 SYRINGE in 1 BOX > 2 mL in 1 SYRINGE1 box2022-01-180000-00-00NoNoCurrent