Naloxone Hydrochloride

Product NDC
67457-987
11-digit product format
674570987
Labeler code
67457
Product ID
67457-987_4f711224-09e7-4c4e-8780-e7e76c572f8c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
naloxone hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Mylan Institutional LLC
Application
ANDA205014
Marketing category
ANDA
Marketing start
2019-11-20
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
67457-987NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]3Legacy NDC20210721_8eb8cb6a-8e50-4f22-a516-6831552baa0d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67457-987-106745709871010 VIAL, MULTI-DOSE in 1 CARTON (67457-987-10) > 10 mL in 1 VIAL, MULTI-DOSE (67457-987-00) 2019-11-200000-00-00NoNoCurrent