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Labetalol hydrochloride - Medication Information

Product NDC Code 70771-1164
Drug Name

Labetalol hydrochloride

Type Generic
Pharm Class Adrenergic beta-Antagonists [MoA],
beta-Adrenergic Blocker [EPC]
Active Ingredients
Labetalol hydrochloride 200 mg/1
Route ORAL
Dosage Form TABLET, FILM COATED
RxCUI drug identifier 896758,
896762,
896766
Application Number ANDA207743
Labeler Name Zydus Lifesciences Limited
Packages
Package NDC Code Description
70771-1164-1 100 tablet, film coated in 1 bottle (70771-1164-1)
70771-1164-3 30 tablet, film coated in 1 bottle (70771-1164-3)
70771-1164-5 500 tablet, film coated in 1 bottle (70771-1164-5)
70771-1164-9 90 tablet, film coated in 1 bottle (70771-1164-9)
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Spl product data elements

Usually a list of ingredients in a drug product.
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

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
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

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API