Labetalol Hydrochloride (Page 5 of 5)

HOW SUPPLIED

Labetalol hydrochloride injection, 5 mg/mL, is supplied in:


NDC 72266-103-41, 200 mg/40 mL Multi-Dose Vial, Carton of 1.

Store at 20°C to 25ºC (68°F to 77°F). See USP Controlled Room Temperature. Protect from freezing and light.

Distributed by:

Fosun Pharma USA Inc.
Princeton, NJ 08540

Novaplus is a registered trademark of Vizient, Inc.

Made in India

Revised: January 2021

PSLEA-020481-00

VIAL LABEL 40 mL

NDC 72266- 103-41

Labetalol HCL Injection, USP

200 mg/40 mL

(5 mg/mL)

FOR INTRAVENOUS INJECTION ONLY

Labetalol 40mL label

vial
(click image for full-size original)

Labetalol 40mL carton

NDC 72266- 103-41

carton
(click image for full-size original)
LABETALOL HYDROCHLORIDE
labetalol hydrochloride injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72266-103
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LABETALOL HYDROCHLORIDE (LABETALOL) LABETALOL HYDROCHLORIDE 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DEXTROSE 45 mg in 1 mL
EDETATE DISODIUM 0.1 mg in 1 mL
METHYLPARABEN 0.8 mg in 1 mL
PROPYLPARABEN 0.1 mg in 1 mL
CITRIC ACID MONOHYDRATE
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72266-103-41 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
1 40 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (72266-103-41)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090699 03/31/2021
Labeler — Fosun Pharma USA Inc. (080920998)

Revised: 03/2021 Fosun Pharma USA Inc.

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