Labetalol Hydrochloride Tablet, Film Coated
FDA Label NDC 70771-1165

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zydus Lifesciences Limited for the product Labetalol Hydrochloride (NDC 70771-1165). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Package Label.Principal Display Panel

NDC 70771-1163-3

Labetalol  hydrochloride tablets, 100 mg

Rx only

30 tablets

Labetalol  Hydrochloride Tablets (Ff56a8ca 43a3 484a B91a C6ef13d9810a 02)

Labetalol Hydrochloride Tablets (Ff56a8ca 43a3 484a B91a C6ef13d9810a 02)

NDC 70771-1164-3

Labetalol  hydrochloride tablets, 200 mg

Rx only

30 tablets

Labetalol  Hydrochloride Tablets (Ff56a8ca 43a3 484a B91a C6ef13d9810a 03)

Labetalol Hydrochloride Tablets (Ff56a8ca 43a3 484a B91a C6ef13d9810a 03)

NDC 70771-1165-3

Labetalol  hydrochloride tablets, 300 mg

Rx only

30 tablets

Labetalol  Hydrochloride Tablets (Ff56a8ca 43a3 484a B91a C6ef13d9810a 04)

Labetalol Hydrochloride Tablets (Ff56a8ca 43a3 484a B91a C6ef13d9810a 04)

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