losartan potassium and hydrochlorothiazide

Generic: losartan potassium and hydrochlorothiazide

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name losartan potassium and hydrochlorothiazide
Generic Name losartan potassium and hydrochlorothiazide
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydrochlorothiazide 25 mg/1, losartan potassium 100 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-671
Product ID 71610-671_2d778122-9382-4e15-a927-d652112b3606
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204832
Listing Expiration 2026-12-31
Marketing Start 2017-07-21

Pharmacologic Class

Established (EPC)
thiazide diuretic [epc]
Chemical Structure
thiazides [cs]
Physiologic Effect
increased diuresis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610671
Hyphenated Format 71610-671

Supplemental Identifiers

RxCUI
979471
UNII
0J48LPH2TH 3ST302B24A
NUI
N0000175359 N0000175419 M0471776

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 losartan potassium and hydrochlorothiazide (source: ndc)
Generic Name losartan potassium and hydrochlorothiazide (source: ndc)
Application Number ANDA204832 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-671-30)
  • 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-671-45)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-671-53)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-671-60)
  • 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-671-70)
  • 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-671-80)
source: ndc

Packages (6)

71610-671-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-671-30) 71610-671-45 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-671-45) 71610-671-53 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-671-53) 71610-671-60 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-671-60) 71610-671-70 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-671-70) 71610-671-80 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-671-80)

Ingredients (2)

hydrochlorothiazide (25 mg/1) losartan potassium (100 mg/1)

Linked Drug Pages (1)

losartan potassium and hydrochlorothiazide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2d778122-9382-4e15-a927-d652112b3606", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "unii": ["0J48LPH2TH", "3ST302B24A"], "rxcui": ["979471"], "spl_set_id": ["35099fd1-1bc9-428b-9b9c-71f574cc4156"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-671-30)", "package_ndc": "71610-671-30", "marketing_start_date": "20221102"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-671-45)", "package_ndc": "71610-671-45", "marketing_start_date": "20221102"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-671-53)", "package_ndc": "71610-671-53", "marketing_start_date": "20221103"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-671-60)", "package_ndc": "71610-671-60", "marketing_start_date": "20221102"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-671-70)", "package_ndc": "71610-671-70", "marketing_start_date": "20221102"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-671-80)", "package_ndc": "71610-671-80", "marketing_start_date": "20221102"}], "brand_name": "losartan potassium and hydrochlorothiazide", "product_id": "71610-671_2d778122-9382-4e15-a927-d652112b3606", "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": "71610-671", "generic_name": "losartan potassium and hydrochlorothiazide", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "losartan potassium and hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "25 mg/1"}, {"name": "LOSARTAN POTASSIUM", "strength": "100 mg/1"}], "application_number": "ANDA204832", "marketing_category": "ANDA", "marketing_start_date": "20170721", "listing_expiration_date": "20261231"}