NALOXONE HYDROCHLORIDE

Product NDC
51662-1544
11-digit product format
516621544
Labeler code
51662
Product ID
51662-1544_10352ea7-15c5-5c6c-e063-6394a90ae130
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NALOXONE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA212455
Marketing category
ANDA
Marketing start
2021-08-08
Substance
NALOXONE HYDROCHLORIDE
Active strength
.4 mg/mL
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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
51662-1544-1516621544011 mL in 1 VIAL, SINGLE-DOSE (51662-1544-1) 1 ml2021-08-08NoNoHistorical
51662-1544-35166215440310 POUCH in 1 CASE (51662-1544-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1544-2) / 1 mL in 1 VIAL, SINGLE-DOSE10 pouch2022-04-22NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
NALOXONE HYDROCHLORIDE INJECTION, USP 0.4mg PER mL 1mLHF Acquisition Co LLC, DBA HealthFirst2024-01-30HUMAN PRESCRIPTION DRUG LABEL3