Zituvimet® Xr (sitagliptin And Metformin Hydrochloride) Extended-release Tablets, For Oral Use

SPL v2

SPL

SPL Set ID 4bade493-499e-434a-97a0-26ca68917623

Route

ORAL

Published

Effective Date 2026-01-05

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Sitagliptin (50 mg) Metformin (1000 mg)

Inactive Ingredients

Anhydrous Dibasic Calcium Phosphate Croscarmellose Sodium Fd&c Yellow No. 6 Ferric Oxide Yellow Hypromellose 2208 (100000 Mpa.s) Hypromellose 2208 (200000 Mpa.s) Magnesium Stearate Malic Acid Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Povidone Silicon Dioxide Sodium Stearyl Fumarate Starch, Corn Talc Titanium Dioxide Ferric Oxide Red

Identifiers & Packaging

Pill Appearance

Imprint: 1806 Shape: oval Color: yellow Color: orange Color: brown Size: 22 mm Size: 18 mm Score: 1

Marketing Status

NDA Active Since 2024-10-31

Description

NDC 70771-1879-6 ZITUVIMET ® XR (sitagliptin and metformin hydrochloride extended-release) tablets 50 mg/500 mg 60 Tablets Rx only NDC 70771-1880-6 ZITUVIMET ® XR (sitagliptin and metformin hydrochloride extended-release) tablets 50 mg/1,000 mg 60 Tablets Rx only NDC 70771-1881-3 ZITUVIMET ® XR (sitagliptin and metformin hydrochloride extended-release) tablets 100 mg/1,000 mg 30 Tablets Rx only

Medication Information

Description

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

NDC 70771-1880-6

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

50 mg/1,000 mg

60 Tablets

Rx only

NDC 70771-1881-3

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

100 mg/1,000 mg

30 Tablets

Rx only

Structured Label Content

Package Label.principal Display Panel (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

NDC 70771-1880-6

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

50 mg/1,000 mg

60 Tablets

Rx only

NDC 70771-1881-3

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

100 mg/1,000 mg

30 Tablets

Rx only

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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 NDC 70771-1880-6 ZITUVIMET ® XR (sitagliptin and metformin hydrochloride extended-release) tablets 50 mg/1,000 mg 60 Tablets Rx only NDC 70771-1881-3 ZITUVIMET ® XR (sitagliptin and metformin hydrochloride extended-release) tablets 100 mg/1,000 mg 30 Tablets Rx only"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:51:55.517170 · Updated: 2026-03-14T22:42:19.657154