Candesartan Cilexetil And Hydrochlorothiazide Tablets Usp, For Oral Use

SPL v5

SPL

SPL Set ID cb328bc1-5738-4620-b2b3-442e98388a86

Route

ORAL

Published

Effective Date 2018-04-09

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Candesartan (16 mg) Hydrochlorothiazide (12.5 mg)

Inactive Ingredients

Carboxymethylcellulose Calcium Starch, Corn Glyceryl Mono- And Dicaprylocaprate Lactose Monohydrate Magnesium Stearate Hydroxypropyl Cellulose (110000 Wamw)

Identifiers & Packaging

Pill Appearance

Imprint: 41;6 Shape: oval Color: white Size: 10 mm Size: 11 mm Score: 2

Marketing Status

ANDA Active Since 2018-04-14

Description

NDC 70771-1325-0 in bottle of 1000 tablets Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 16 mg/12.5 mg R x only 1000 tablets NDC 70771-1326-0 in bottle of 1000 tablets Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/12.5 mg R x only 1000 tablets NDC 70771-1327-0 in bottle of 1000 tablets Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/25 mg R x only 1000 tablets

Medication Information

Description

Package Label.principal Display Panel

NDC 70771-1325-0 in bottle of 1000 tablets

Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 16 mg/12.5 mg

R_xonly

1000 tablets

NDC 70771-1326-0 in bottle of 1000 tablets

Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/12.5 mg

R_xonly

1000 tablets

NDC 70771-1327-0 in bottle of 1000 tablets

Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/25 mg

R_xonly

1000 tablets

Structured Label Content

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

NDC 70771-1325-0 in bottle of 1000 tablets

Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 16 mg/12.5 mg

R_xonly

1000 tablets

NDC 70771-1326-0 in bottle of 1000 tablets

Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/12.5 mg

R_xonly

1000 tablets

NDC 70771-1327-0 in bottle of 1000 tablets

Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/25 mg

R_xonly

1000 tablets

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 70771-1325-0 in bottle of 1000 tablets Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 16 mg/12.5 mg R x only 1000 tablets NDC 70771-1326-0 in bottle of 1000 tablets Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/12.5 mg R x only 1000 tablets NDC 70771-1327-0 in bottle of 1000 tablets Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/25 mg R x only 1000 tablets"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:43:43.856411 · Updated: 2026-03-14T22:17:00.667686