Prescription Drug Information: NALOXONE HYDROCHLORIDE (Page 4 of 4)

HOW SUPPLIED

1 mg/mL naloxone hydrochloride injection USP, for intravenous, intramuscular and subcutaneous administration.

Available as follows:

1 mg/mL

2 mL single dose disposable prefilled syringes, in the MIN-I-JET® system with 21 G. x 11/2” needle. Shrink Wrapped Packages of 10.

NDC 76329-1469-1 Stock No. 1469 (contains no preservative)

2 mL single dose disposable Luer-JetTM Luer-Lock Prefilled Syringe. Shrink Wrapped Packages of 10.

NDC 76329-3369-1 Stock No. 3369 (contains no preservative)

Syringe Assembly Directions:

The MIN-I-JET® syringe with needle, illustrated below, is the basic unit upon which all the other syringe systems are built; slight adaptations and/ or additional auxiliary parts create the other syringe systems. Assembly directions remain essentially the same.

USE ASEPTIC TECHNIQUE

Do not assemble until ready to use.

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SPL UNCLASSIFIED

Store at 25˚C (77˚F); excursions permitted to 15˚-30˚C (59˚-86˚F). [See USP Controlled Room Temperature.]
Protect from light.
Store in carton until contents have been used.

INTERNATIONAL MEDICATION SYSTEMS, LIMITEDSO. EL MONTE, CA 91733, U.S.A. REV. 11-13

An Amphastar Pharmaceuticals Company

© INTERNATIONAL MEDICATION SYSTEMS, LIMITED 2013

SAMPLE PACKAGE LABEL

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NALOXONE HYDROCHLORIDE naloxone hydrochloride injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52584-978(NDC:76329-1469)
Route of Administration PARENTERAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NALOXONE HYDROCHLORIDE (NALOXONE) NALOXONE HYDROCHLORIDE 1 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52584-978-01 1 BOX in 1 BAG contains a BOX
1 1 SYRINGE in 1 BOX This package is contained within the BAG (52584-978-01) and contains a SYRINGE
1 2 mL in 1 SYRINGE This package is contained within a BOX and a BAG (52584-978-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072076 12/06/2013
Labeler — General Injectables & Vaccines, Inc (108250663)

Revised: 11/2021 General Injectables & Vaccines, Inc

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