losartan potassium and hydrochlorothiazide

Generic: losartan potassium and hydrochlorothiazide

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

hydrochlorothiazide 12.5 mg/1, losartan potassium 50 mg/1

Manufacturer
Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-048
Product ID 62332-048_a9657dc9-2be3-4719-a5b7-fbf22603275e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091617
Listing Expiration 2027-12-31
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 62332048
Hyphenated Format 62332-048

Supplemental Identifiers

RxCUI
979464 979468 979471
UPC
0362332048304 0362332050307 0362332049301
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
  • 12.5 mg/1
  • 50 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (62332-048-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 30 TABLET, FILM COATED in 1 BOTTLE (62332-048-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (62332-048-90)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (62332-048-91)
source: ndc

Packages (4)

62332-048-10 100 BLISTER PACK in 1 CARTON (62332-048-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK 62332-048-30 30 TABLET, FILM COATED in 1 BOTTLE (62332-048-30) 62332-048-90 90 TABLET, FILM COATED in 1 BOTTLE (62332-048-90) 62332-048-91 1000 TABLET, FILM COATED in 1 BOTTLE (62332-048-91)

Ingredients (2)

hydrochlorothiazide (12.5 mg/1) losartan potassium (50 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": "a9657dc9-2be3-4719-a5b7-fbf22603275e", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0362332048304", "0362332050307", "0362332049301"], "unii": ["0J48LPH2TH", "3ST302B24A"], "rxcui": ["979464", "979468", "979471"], "spl_set_id": ["acecced9-2a61-435d-b7d4-b151cb7b7e5d"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (62332-048-10)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "62332-048-10", "marketing_start_date": "20160523"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (62332-048-30)", "package_ndc": "62332-048-30", "marketing_start_date": "20160523"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (62332-048-90)", "package_ndc": "62332-048-90", "marketing_start_date": "20160523"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (62332-048-91)", "package_ndc": "62332-048-91", "marketing_start_date": "20160523"}], "brand_name": "Losartan Potassium and Hydrochlorothiazide", "product_id": "62332-048_a9657dc9-2be3-4719-a5b7-fbf22603275e", "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": "62332-048", "generic_name": "Losartan Potassium and Hydrochlorothiazide", "labeler_name": "Alembic Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Losartan Potassium and Hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}, {"name": "LOSARTAN POTASSIUM", "strength": "50 mg/1"}], "application_number": "ANDA091617", "marketing_category": "ANDA", "marketing_start_date": "20160523", "listing_expiration_date": "20271231"}