micardis hct

Generic: telmisartan and hydrochlorothiazide

Labeler: boehringer ingelheim pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name micardis hct
Generic Name telmisartan and hydrochlorothiazide
Labeler boehringer ingelheim pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydrochlorothiazide 25 mg/1, telmisartan 80 mg/1

Manufacturer
Boehringer Ingelheim Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0597-0042
Product ID 0597-0042_ea1ff12a-df9e-477b-9e91-f89381987c6d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021162
Listing Expiration 2026-12-31
Marketing Start 2000-12-01

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 05970042
Hyphenated Format 0597-0042

Supplemental Identifiers

RxCUI
283316 283317 477130 749833 749837 749841
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 micardis hct (source: ndc)
Generic Name telmisartan and hydrochlorothiazide (source: ndc)
Application Number NDA021162 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 80 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (0597-0042-37) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0597-0042-37 3 BLISTER PACK in 1 CARTON (0597-0042-37) / 10 TABLET in 1 BLISTER PACK

Ingredients (2)

hydrochlorothiazide (25 mg/1) telmisartan (80 mg/1)

Linked Drug Pages (1)

Micardis HCT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ea1ff12a-df9e-477b-9e91-f89381987c6d", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "unii": ["0J48LPH2TH", "U5SYW473RQ"], "rxcui": ["283316", "283317", "477130", "749833", "749837", "749841"], "spl_set_id": ["b078dae2-664d-4144-847a-3b9d9b557402"], "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": ["Boehringer Ingelheim Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (0597-0042-37)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "0597-0042-37", "marketing_start_date": "20001201"}], "brand_name": "Micardis HCT", "product_id": "0597-0042_ea1ff12a-df9e-477b-9e91-f89381987c6d", "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": "0597-0042", "generic_name": "telmisartan and hydrochlorothiazide", "labeler_name": "Boehringer Ingelheim Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Micardis HCT", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "25 mg/1"}, {"name": "TELMISARTAN", "strength": "80 mg/1"}], "application_number": "NDA021162", "marketing_category": "NDA", "marketing_start_date": "20001201", "listing_expiration_date": "20261231"}