irbesartan and hydrochlorothiazide (29300-216)

Drug Facts

Product Profile

Brand Name irbesartan and hydrochlorothiazide

Generic Name irbesartan and hydrochlorothiazide

Labeler unichem pharmaceuticals (usa), inc.

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

hydrochlorothiazide 12.5 mg/1, irbesartan 300 mg/1

Manufacturer

Unichem Pharmaceuticals (USA), Inc.

Identifiers & Regulatory

Product NDC 29300-216

Product ID 29300-216_a2e7c9d1-50c4-4a14-8dd5-8dfc6d63a29a

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA207018

Listing Expiration 2026-12-31

Marketing Start 2017-09-19

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 29300216

Hyphenated Format 29300-216

Supplemental Identifiers

RxCUI

310792 310793

UNII

0J48LPH2TH J0E2756Z7N

NUI

N0000175359 N0000175419 M0471776 N0000000070 N0000175561

Packaging Origin

Original Packager

true

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 ANDA207018 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

12.5 mg/1
300 mg/1

source: ndc

Packaging

1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-216-10)
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-216-13)
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-216-19)

source: ndc

Packages (3)

29300-216-10 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-216-10) 29300-216-13 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-216-13) 29300-216-19 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-216-19)

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": "a2e7c9d1-50c4-4a14-8dd5-8dfc6d63a29a", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "unii": ["0J48LPH2TH", "J0E2756Z7N"], "rxcui": ["310792", "310793"], "spl_set_id": ["181324c5-256f-4570-a0bb-8bc908deb2e2"], "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": ["Unichem Pharmaceuticals (USA), Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-216-10)", "package_ndc": "29300-216-10", "marketing_start_date": "20180331"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-216-13)", "package_ndc": "29300-216-13", "marketing_start_date": "20180331"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-216-19)", "package_ndc": "29300-216-19", "marketing_start_date": "20180331"}], "brand_name": "Irbesartan and Hydrochlorothiazide", "product_id": "29300-216_a2e7c9d1-50c4-4a14-8dd5-8dfc6d63a29a", "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": "29300-216", "generic_name": "Irbesartan and Hydrochlorothiazide", "labeler_name": "Unichem Pharmaceuticals (USA), 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": "ANDA207018", "marketing_category": "ANDA", "marketing_start_date": "20170919", "listing_expiration_date": "20261231"}