NALOXONE HYDROCHLORIDE

Product NDC
71205-707
11-digit product format
712050707
Labeler code
71205
Product ID
71205-707_8d529b4c-85fd-4e50-9443-9080825307bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
naloxone hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Proficient Rx LP
Application
ANDA211951
Marketing category
ANDA
Marketing start
2022-06-21
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
71205-707-02712050707022 VIAL, SINGLE-DOSE in 1 CARTON (71205-707-02) / .1 mL in 1 VIAL, SINGLE-DOSE2022-10-20NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
NALOXONE HYDROCHLORIDEProficient Rx LP2022-10-01HUMAN PRESCRIPTION DRUG LABEL1