telmisartan and hydrochlorothiazide (68462-840)

Drug Facts

Product Profile

Brand Name telmisartan and hydrochlorothiazide

Generic Name telmisartan and hydrochlorothiazide

Labeler glenmark pharmaceuticals inc., usa

Dosage Form TABLET

Routes

ORAL

Active Ingredients

hydrochlorothiazide 12.5 mg/1, telmisartan 40 mg/1

Manufacturer

Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-840

Product ID 68462-840_697f1231-2483-4e0b-9e23-aeb576fa6171

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA202544

Listing Expiration 2027-12-31

Marketing Start 2019-03-04

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 68462840

Hyphenated Format 68462-840

Supplemental Identifiers

RxCUI

283316 283317 477130

UPC

0368462842133 0368462841136 0368462840139

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 ANDA202544 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

12.5 mg/1
40 mg/1

source: ndc

Packaging

3 BLISTER PACK in 1 CARTON (68462-840-13) / 10 TABLET in 1 BLISTER PACK

source: ndc

Packages (1)

68462-840-13 3 BLISTER PACK in 1 CARTON (68462-840-13) / 10 TABLET in 1 BLISTER PACK

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": "697f1231-2483-4e0b-9e23-aeb576fa6171", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "upc": ["0368462842133", "0368462841136", "0368462840139"], "unii": ["0J48LPH2TH", "U5SYW473RQ"], "rxcui": ["283316", "283317", "477130"], "spl_set_id": ["1e55800d-f77c-4950-a6d7-2055f4c7ea17"], "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": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (68462-840-13)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "68462-840-13", "marketing_start_date": "20190304"}], "brand_name": "Telmisartan and Hydrochlorothiazide", "product_id": "68462-840_697f1231-2483-4e0b-9e23-aeb576fa6171", "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": "68462-840", "generic_name": "Telmisartan and Hydrochlorothiazide", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "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": "ANDA202544", "marketing_category": "ANDA", "marketing_start_date": "20190304", "listing_expiration_date": "20271231"}