telmisartan and hydrochlorothiazide

Generic: telmisartan and hydrochlorothiazide

Labeler: lifestar pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name telmisartan and hydrochlorothiazide
Generic Name telmisartan and hydrochlorothiazide
Labeler lifestar pharma llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydrochlorothiazide 12.5 mg/1, telmisartan 80 mg/1

Manufacturer
Lifestar Pharma LLC

Identifiers & Regulatory

Product NDC 70756-316
Product ID 70756-316_70efda7e-0c71-4faf-be4e-ef281d7cc297
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218406
Listing Expiration 2026-12-31
Marketing Start 2025-12-25

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 70756316
Hyphenated Format 70756-316

Supplemental Identifiers

RxCUI
283316 283317 477130
UPC
0370756315018 0370756316015 0370756317319 0370756317012 0370756315315
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 ANDA218406 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
  • 80 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (70756-316-30)
  • 3 BLISTER PACK in 1 CARTON (70756-316-31) / 10 TABLET in 1 BLISTER PACK
  • 10 BLISTER PACK in 1 CARTON (70756-316-99) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (3)

70756-316-30 30 TABLET in 1 BOTTLE (70756-316-30) 70756-316-31 3 BLISTER PACK in 1 CARTON (70756-316-31) / 10 TABLET in 1 BLISTER PACK 70756-316-99 10 BLISTER PACK in 1 CARTON (70756-316-99) / 10 TABLET in 1 BLISTER PACK

Ingredients (2)

hydrochlorothiazide (12.5 mg/1) telmisartan (80 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": "70efda7e-0c71-4faf-be4e-ef281d7cc297", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "upc": ["0370756315018", "0370756316015", "0370756317319", "0370756317012", "0370756315315"], "unii": ["0J48LPH2TH", "U5SYW473RQ"], "rxcui": ["283316", "283317", "477130"], "spl_set_id": ["0c1bd0f4-034e-486c-ae46-2855c8c9ebda"], "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": ["Lifestar Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (70756-316-30)", "package_ndc": "70756-316-30", "marketing_start_date": "20251225"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (70756-316-31)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "70756-316-31", "marketing_start_date": "20251225"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70756-316-99)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "70756-316-99", "marketing_start_date": "20251225"}], "brand_name": "telmisartan and hydrochlorothiazide", "product_id": "70756-316_70efda7e-0c71-4faf-be4e-ef281d7cc297", "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": "70756-316", "generic_name": "telmisartan and hydrochlorothiazide", "labeler_name": "Lifestar Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "telmisartan and hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}, {"name": "TELMISARTAN", "strength": "80 mg/1"}], "application_number": "ANDA218406", "marketing_category": "ANDA", "marketing_start_date": "20251225", "listing_expiration_date": "20261231"}