NALOXONE HCl

Product NDC
51662-1620
11-digit product format
516621620
Labeler code
51662
Product ID
51662-1620_100bc933-5bf3-8de2-e063-6294a90a7ba6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NALOXONE HCl
Dosage form
SPRAY
Route
NASAL
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA211951
Marketing category
ANDA
Marketing start
2023-04-10
Substance
NALOXONE HYDROCHLORIDE
Active strength
4 mg/.1mL
Pharmacologic classes
Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
F850569PQRNALOXONE HYDROCHLORIDE357-08-4NALOXONE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51662-1620-151662162001.1 mL in 1 VIAL, SINGLE-DOSE (51662-1620-1) 2023-04-10NoNoHistorical
51662-1620-2516621620022 VIAL, SINGLE-DOSE in 1 CARTON (51662-1620-2) / .1 mL in 1 VIAL, SINGLE-DOSE2023-04-10NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
NALOXONE HCl NASAL SPRAY 4mg/.1mLHF Acquisition Co LLC, DBA HealthFirst2024-01-28HUMAN PRESCRIPTION DRUG LABEL2