Varenicline Tablets

SPL v2

SPL

SPL Set ID 481b94af-ee34-44be-8ca1-b2415525efac

Route

ORAL

Published

Effective Date 2023-09-28

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Varenicline (0.5 mg)

Inactive Ingredients

Anhydrous Dibasic Calcium Phosphate Croscarmellose Sodium Hypromellose 2910 (3 Mpa.s) Hypromellose 2910 (6 Mpa.s) Magnesium Stearate Cellulose, Microcrystalline Silicon Dioxide Titanium Dioxide Triacetin Fd&c Blue No. 1 Aluminum Lake

Identifiers & Packaging

Pill Appearance

Imprint: ZV2 Shape: capsule Color: white Color: blue Size: 8 mm Size: 10 mm Score: 1

Marketing Status

ANDA Active Since 2023-06-13

Description

NDC 70771-1773-6 Varenicline Tablets, 0.5 mg 56 Tablets Rx only NDC 70771-1774-6 Varenicline Tablets, 1 mg 56 Tablets Rx only

Medication Information

Description

NDC 70771-1773-6 Varenicline Tablets, 0.5 mg 56 Tablets Rx only NDC 70771-1774-6 Varenicline Tablets, 1 mg 56 Tablets Rx only

Package Label.principal Display Panel

NDC 70771-1773-6

Varenicline Tablets, 0.5 mg

56 Tablets

Rx only

NDC 70771-1774-6

Varenicline Tablets, 1 mg

56 Tablets

Rx only

Structured Label Content

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC 70771-1773-6

Varenicline Tablets, 0.5 mg

56 Tablets

Rx only

NDC 70771-1774-6

Varenicline Tablets, 1 mg

56 Tablets

Rx only

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 70771-1773-6 Varenicline Tablets, 0.5 mg 56 Tablets Rx only NDC 70771-1774-6 Varenicline Tablets, 1 mg 56 Tablets Rx only"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:39:00.022700 · Updated: 2026-03-14T21:56:18.712126