irbesartan and hydrochlorothiazide (70518-1550)

Drug Facts

Product Profile

Brand Name irbesartan and hydrochlorothiazide

Generic Name irbesartan and hydrochlorothiazide

Labeler remedyrepack inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

hydrochlorothiazide 12.5 mg/1, irbesartan 300 mg/1

Manufacturer

REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-1550

Product ID 70518-1550_494c124c-6d02-4add-e063-6394a90a26f7

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA203072

Listing Expiration 2027-12-31

Marketing Start 2018-10-18

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 705181550

Hyphenated Format 70518-1550

Supplemental Identifiers

RxCUI

310793

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 ANDA203072 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

12.5 mg/1
300 mg/1

source: ndc

Packaging

90 TABLET in 1 BOTTLE, PLASTIC (70518-1550-0)
90 TABLET in 1 BOTTLE, PLASTIC (70518-1550-1)

source: ndc

Packages (2)

70518-1550-0 90 TABLET in 1 BOTTLE, PLASTIC (70518-1550-0) 70518-1550-1 90 TABLET in 1 BOTTLE, PLASTIC (70518-1550-1)

Ingredients (2)

hydrochlorothiazide (12.5 mg/1) irbesartan (300 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": "494c124c-6d02-4add-e063-6394a90a26f7", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "unii": ["0J48LPH2TH", "J0E2756Z7N"], "rxcui": ["310793"], "spl_set_id": ["88aaa2a1-13be-4f56-ace6-66e899028007"], "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": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (70518-1550-0)", "package_ndc": "70518-1550-0", "marketing_start_date": "20181018"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (70518-1550-1)", "package_ndc": "70518-1550-1", "marketing_start_date": "20250827"}], "brand_name": "Irbesartan and Hydrochlorothiazide", "product_id": "70518-1550_494c124c-6d02-4add-e063-6394a90a26f7", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "70518-1550", "generic_name": "Irbesartan and Hydrochlorothiazide", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Irbesartan and Hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}, {"name": "IRBESARTAN", "strength": "300 mg/1"}], "application_number": "ANDA203072", "marketing_category": "ANDA", "marketing_start_date": "20181018", "listing_expiration_date": "20271231"}