Zituvimet Xr Tablet, Film Coated, Extended Release
FDA Label NDC 70771-1880

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 Zituvimet Xr (NDC 70771-1880). 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.

Label Section Quick Index

Package Label.Principal Display Panel

NDC 70771-1879-6

ZITUVIMET XR (sitagliptin and metformin hydrochloride extended-release) tablets

50 mg/500 mg

60 Tablets

Rx only

50 mg/500 mg (F1099545 0696 4217 990e D03afa51d8f9 01)

50 mg/500 mg (F1099545 0696 4217 990e D03afa51d8f9 01)

NDC 70771-1880-6

ZITUVIMET XR (sitagliptin and metformin hydrochloride extended-release) tablets

50 mg/1,000 mg

60 Tablets

Rx only

50 mg-1000 mg (F1099545 0696 4217 990e D03afa51d8f9 02)

50 mg-1000 mg (F1099545 0696 4217 990e D03afa51d8f9 02)

NDC 70771-1881-3

ZITUVIMET XR (sitagliptin and metformin hydrochloride extended-release) tablets

100 mg/1,000 mg

30 Tablets

Rx only

100 mg-1000 mg (F1099545 0696 4217 990e D03afa51d8f9 03)

100 mg-1000 mg (F1099545 0696 4217 990e D03afa51d8f9 03)

* Please review the disclaimer below.