NALOXONE HYDROCHLORIDE

Product NDC
50090-6963
11-digit product format
500906963
Labeler code
50090
Product ID
50090-6963_7a0088db-1e25-49db-9a22-c99cd6adfd8f
Type
HUMAN OTC DRUG
Nonproprietary name
naloxone hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
A-S Medication Solutions
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
50090-6963-0500906963002 VIAL, SINGLE-DOSE in 1 CARTON (50090-6963-0) / .1 mL in 1 VIAL, SINGLE-DOSE2023-12-20NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Naloxone HCl Nasal Spray Drug FactsA-S Medication Solutions2023-12-27HUMAN OTC DRUG LABEL2