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FDA Drug information

Labetalol Hydrochloride

Read time: 1 mins
Marketing start date: 20 Jul 2024

Summary of product characteristics


Effective Time

20221018

Version

5

Spl Product Data Elements

Labetalol Hydrochloride Labetalol Hydrochloride LABETALOL HYDROCHLORIDE LABETALOL ALUMINUM OXIDE D&C YELLOW NO. 10 FERRIC OXIDE RED FERRIC OXIDE YELLOW HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN TALC TITANIUM DIOXIDE YELLOW BICONVEX 7;98 Labetalol Hydrochloride Labetalol Hydrochloride LABETALOL HYDROCHLORIDE LABETALOL HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN TITANIUM DIOXIDE OFF-WHITE BICONVEX 7;99 Labetalol Hydrochloride Labetalol Hydrochloride LABETALOL HYDROCHLORIDE LABETALOL FD&C BLUE NO. 1--ALUMINUM LAKE FERRIC OXIDE YELLOW HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN TALC TITANIUM DIOXIDE LIGHT GREEN BICONVEX 800

Application Number

ANDA207743

Brand Name

Labetalol Hydrochloride

Generic Name

Labetalol Hydrochloride

Product Ndc

70771-1164

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1163-3 Labetalol hydrochloride tablets, 100 mg Rx only 30 tablets NDC 70771-1164-3 Labetalol hydrochloride tablets, 200 mg Rx only 30 tablets NDC 70771-1165-3 Labetalol hydrochloride tablets, 300 mg Rx only 30 tablets Labetalol hydrochloride tablets Labetalol hydrochloride tablets Labetalol hydrochloride tablets

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