irbesartan and hydrochlorothiazide (63187-653)

Drug Facts

Product Profile

Brand Name irbesartan and hydrochlorothiazide

Generic Name irbesartan and hydrochlorothiazide

Labeler proficient rx lp

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

hydrochlorothiazide 12.5 mg/1, irbesartan 150 mg/1

Manufacturer

Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-653

Product ID 63187-653_2c82bb30-406c-4b3e-9834-ed32ea065bf0

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA202414

Listing Expiration 2026-12-31

Marketing Start 2012-09-27

Pharmacologic Class

Established (EPC)

thiazide diuretic [epc] angiotensin 2 receptor blocker [epc]

Mechanism of Action

angiotensin 2 receptor antagonists [moa]

Chemical Structure

thiazides [cs]

Physiologic Effect

increased diuresis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187653

Hyphenated Format 63187-653

Supplemental Identifiers

RxCUI

310792

UNII

0J48LPH2TH J0E2756Z7N

NUI

N0000175359 N0000175419 M0471776 N0000000070 N0000175561

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name irbesartan and hydrochlorothiazide (source: ndc)

Generic Name irbesartan and hydrochlorothiazide (source: ndc)

Application Number ANDA202414 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

12.5 mg/1
150 mg/1

source: ndc

Packaging

30 TABLET, FILM COATED in 1 BOTTLE (63187-653-30)
60 TABLET, FILM COATED in 1 BOTTLE (63187-653-60)
90 TABLET, FILM COATED in 1 BOTTLE (63187-653-90)

source: ndc

Packages (3)

63187-653-30 30 TABLET, FILM COATED in 1 BOTTLE (63187-653-30) 63187-653-60 60 TABLET, FILM COATED in 1 BOTTLE (63187-653-60) 63187-653-90 90 TABLET, FILM COATED in 1 BOTTLE (63187-653-90)

Ingredients (2)

hydrochlorothiazide (12.5 mg/1) irbesartan (150 mg/1)

Linked Drug Pages (1)

Irbesartan and Hydrochlorothiazide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "2c82bb30-406c-4b3e-9834-ed32ea065bf0", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "unii": ["0J48LPH2TH", "J0E2756Z7N"], "rxcui": ["310792"], "spl_set_id": ["97b09783-7bba-4f7a-b1b3-86ccf12c7ecc"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]", "Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63187-653-30)", "package_ndc": "63187-653-30", "marketing_start_date": "20181201"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (63187-653-60)", "package_ndc": "63187-653-60", "marketing_start_date": "20181201"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (63187-653-90)", "package_ndc": "63187-653-90", "marketing_start_date": "20181201"}], "brand_name": "Irbesartan and Hydrochlorothiazide", "product_id": "63187-653_2c82bb30-406c-4b3e-9834-ed32ea065bf0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "63187-653", "generic_name": "Irbesartan and Hydrochlorothiazide", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Irbesartan and Hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}, {"name": "IRBESARTAN", "strength": "150 mg/1"}], "application_number": "ANDA202414", "marketing_category": "ANDA", "marketing_start_date": "20120927", "listing_expiration_date": "20261231"}