telmisartan and hydrochlorothiazide (43547-441)

Drug Facts

Product Profile

Brand Name telmisartan and hydrochlorothiazide

Generic Name telmisartan and hydrochlorothiazide

Labeler solco healthcare llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

hydrochlorothiazide 12.5 mg/1, telmisartan 40 mg/1

Manufacturer

Solco Healthcare LLC

Identifiers & Regulatory

Product NDC 43547-441

Product ID 43547-441_a7294951-f71f-442b-9f8e-2551963db085

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA209028

Listing Expiration 2026-12-31

Marketing Start 2018-02-05

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 43547441

Hyphenated Format 43547-441

Supplemental Identifiers

RxCUI

283316 283317 477130

UPC

0343547442095 0343547441098 0343547443092

UNII

0J48LPH2TH U5SYW473RQ

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 telmisartan and hydrochlorothiazide (source: ndc)

Generic Name telmisartan and hydrochlorothiazide (source: ndc)

Application Number ANDA209028 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

12.5 mg/1
40 mg/1

source: ndc

Packaging

30 TABLET in 1 BOTTLE (43547-441-03)
90 TABLET in 1 BOTTLE (43547-441-09)

source: ndc

Packages (2)

43547-441-03 30 TABLET in 1 BOTTLE (43547-441-03) 43547-441-09 90 TABLET in 1 BOTTLE (43547-441-09)

Ingredients (2)

hydrochlorothiazide (12.5 mg/1) telmisartan (40 mg/1)

Linked Drug Pages (1)

TELMISARTAN AND HYDROCHLOROTHIAZIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "a7294951-f71f-442b-9f8e-2551963db085", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "upc": ["0343547442095", "0343547441098", "0343547443092"], "unii": ["0J48LPH2TH", "U5SYW473RQ"], "rxcui": ["283316", "283317", "477130"], "spl_set_id": ["47c8eee0-f0b7-4bd8-97e9-0029aa1b37db"], "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": ["Solco Healthcare LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (43547-441-03)", "package_ndc": "43547-441-03", "marketing_start_date": "20180205"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (43547-441-09)", "package_ndc": "43547-441-09", "marketing_start_date": "20180205"}], "brand_name": "TELMISARTAN AND HYDROCHLOROTHIAZIDE", "product_id": "43547-441_a7294951-f71f-442b-9f8e-2551963db085", "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": "43547-441", "generic_name": "telmisartan and hydrochlorothiazide", "labeler_name": "Solco Healthcare LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TELMISARTAN AND HYDROCHLOROTHIAZIDE", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}, {"name": "TELMISARTAN", "strength": "40 mg/1"}], "application_number": "ANDA209028", "marketing_category": "ANDA", "marketing_start_date": "20180205", "listing_expiration_date": "20261231"}