Home > National Drug Code (NDC) > Labetalol Hydrochloride

Labetalol Hydrochloride - 68083-111-02 - (Labetalol Hydrochloride)

Alphabetical Index


Drug Information of Labetalol Hydrochloride

Product NDC: 68083-111
Proprietary Name: Labetalol Hydrochloride
Non Proprietary Name: Labetalol Hydrochloride
Active Ingredient(s): 5    mg/mL & nbsp;   Labetalol Hydrochloride
Administration Route(s): INTRAVENOUS
Dosage Form(s): INJECTION, SOLUTION
Coding System: National Drug Codes(NDC)

Labeler Information of Labetalol Hydrochloride

Product NDC: 68083-111
Labeler Name: Gland Pharma Limited
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA090699
Marketing Category: ANDA
Start Marketing Date: 20120419

Package Information of Labetalol Hydrochloride

Package NDC: 68083-111-02
Package Description: 10 VIAL, GLASS in 1 CARTON (68083-111-02) > 40 mL in 1 VIAL, GLASS

NDC Information of Labetalol Hydrochloride

NDC Code 68083-111-02
Proprietary Name Labetalol Hydrochloride
Package Description 10 VIAL, GLASS in 1 CARTON (68083-111-02) > 40 mL in 1 VIAL, GLASS
Product NDC 68083-111
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Labetalol Hydrochloride
Dosage Form Name INJECTION, SOLUTION
Route Name INTRAVENOUS
Start Marketing Date 20120419
Marketing Category Name ANDA
Labeler Name Gland Pharma Limited
Substance Name LABETALOL HYDROCHLORIDE
Strength Number 5
Strength Unit mg/mL
Pharmaceutical Classes Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]

Complete Information of Labetalol Hydrochloride


General Information