NALOXONE HYDROCHLORIDE

Product NDC
72162-2376
11-digit product format
721622376
Labeler code
72162
Product ID
72162-2376_fbe83ce1-e79c-417d-a2f2-432c96e6f1f1
Type
HUMAN OTC DRUG
Nonproprietary name
naloxone hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Bryant Ranch Prepack
Application
ANDA211951
Marketing category
ANDA
Marketing start
2023-07-30
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
72162-2376-2721622376022 VIAL, SINGLE-DOSE in 1 CARTON (72162-2376-2) / .1 mL in 1 VIAL, SINGLE-DOSE (72162-2376-4) 2024-10-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Naloxone HCl Nasal Spray Drug FactsBryant Ranch Prepack2024-10-03HUMAN OTC DRUG LABEL100