Naloxone Hydrochloride

Product NDC
67457-645
11-digit product format
674570645
Labeler code
67457
Product ID
67457-645_ae19fec7-aac8-4fbe-a2aa-ba18a3fe5c9e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
naloxone hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Mylan Institutional LLC
Application
ANDA204997
Marketing category
ANDA
Marketing start
2020-01-24
Marketing end
0000-00-00
Substance
NALOXONE HYDROCHLORIDE
Active strength
0 mg/mL
Pharmacologic classes
Opioid Antagonist [EPC],Opioid Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-645NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]2Legacy NDC20210427_5adbf891-4d73-4026-98b1-174783d68c9a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67457-645-026745706450210 VIAL, SINGLE-DOSE in 1 CARTON (67457-645-02) > 1 mL in 1 VIAL, SINGLE-DOSE (67457-645-00) 2020-01-240000-00-00NoNoCurrent