losartan potassium and hydrochlorothiazide

Generic: losartan potassium and hydrochlorothiazide

Labeler: alembic pharmaceuticals limited
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 alembic pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-450
Product ID 46708-450_d80ae5dd-3bdc-40a4-9589-dfb7f8eabe6d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091617
Listing Expiration 2026-12-31
Marketing Start 2016-05-23

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 46708450
Hyphenated Format 46708-450

Supplemental Identifiers

RxCUI
979464 979468 979471
UPC
0346708448301 0346708449308 0346708450304
UNII
0J48LPH2TH 3ST302B24A
NUI
N0000175359 N0000175419 M0471776

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 losartan potassium and hydrochlorothiazide (source: ndc)
Generic Name losartan potassium and hydrochlorothiazide (source: ndc)
Application Number ANDA091617 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 100 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (46708-450-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 30 TABLET, FILM COATED in 1 BOTTLE (46708-450-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (46708-450-90)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (46708-450-91)
source: ndc

Packages (4)

46708-450-10 100 BLISTER PACK in 1 CARTON (46708-450-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK 46708-450-30 30 TABLET, FILM COATED in 1 BOTTLE (46708-450-30) 46708-450-90 90 TABLET, FILM COATED in 1 BOTTLE (46708-450-90) 46708-450-91 1000 TABLET, FILM COATED in 1 BOTTLE (46708-450-91)

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": "d80ae5dd-3bdc-40a4-9589-dfb7f8eabe6d", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0346708448301", "0346708449308", "0346708450304"], "unii": ["0J48LPH2TH", "3ST302B24A"], "rxcui": ["979464", "979468", "979471"], "spl_set_id": ["bbf7e20d-dfc2-4115-8788-c0cac15a1148"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (46708-450-10)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "46708-450-10", "marketing_start_date": "20160523"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (46708-450-30)", "package_ndc": "46708-450-30", "marketing_start_date": "20160523"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (46708-450-90)", "package_ndc": "46708-450-90", "marketing_start_date": "20160523"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (46708-450-91)", "package_ndc": "46708-450-91", "marketing_start_date": "20160523"}], "brand_name": "Losartan Potassium and Hydrochlorothiazide", "product_id": "46708-450_d80ae5dd-3bdc-40a4-9589-dfb7f8eabe6d", "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": "46708-450", "generic_name": "Losartan Potassium and Hydrochlorothiazide", "labeler_name": "Alembic Pharmaceuticals Limited", "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": "ANDA091617", "marketing_category": "ANDA", "marketing_start_date": "20160523", "listing_expiration_date": "20261231"}