irbesartan and hydrochlorothiazide

Generic: irbesartan and hydrochlorothiazide

Labeler: alembic pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name irbesartan and hydrochlorothiazide
Generic Name irbesartan and hydrochlorothiazide
Labeler alembic pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydrochlorothiazide 25 mg/1, irbesartan 300 mg/1

Manufacturer
Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-053
Product ID 62332-053_08cf62b6-c618-4e6a-877a-4e26ca6e91ee
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091370
Listing Expiration 2027-12-31
Marketing Start 2016-05-23

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 62332053
Hyphenated Format 62332-053

Supplemental Identifiers

RxCUI
310792 310793 485471
UPC
0362332052301 0362332051304 0362332053308
UNII
0J48LPH2TH J0E2756Z7N
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 irbesartan and hydrochlorothiazide (source: ndc)
Generic Name irbesartan and hydrochlorothiazide (source: ndc)
Application Number ANDA091370 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 300 mg/1
source: ndc
Packaging
  • 10 TABLET, FILM COATED in 1 BLISTER PACK (62332-053-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (62332-053-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (62332-053-90)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (62332-053-91)
source: ndc

Packages (4)

62332-053-10 10 TABLET, FILM COATED in 1 BLISTER PACK (62332-053-10) 62332-053-30 30 TABLET, FILM COATED in 1 BOTTLE (62332-053-30) 62332-053-90 90 TABLET, FILM COATED in 1 BOTTLE (62332-053-90) 62332-053-91 1000 TABLET, FILM COATED in 1 BOTTLE (62332-053-91)

Ingredients (2)

hydrochlorothiazide (25 mg/1) irbesartan (300 mg/1)

Linked Drug Pages (1)

Irbesartan and Hydrochlorothiazide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "08cf62b6-c618-4e6a-877a-4e26ca6e91ee", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "upc": ["0362332052301", "0362332051304", "0362332053308"], "unii": ["0J48LPH2TH", "J0E2756Z7N"], "rxcui": ["310792", "310793", "485471"], "spl_set_id": ["e842fa14-b18e-4463-9bf1-a1c8700fe33c"], "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": ["Alembic Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BLISTER PACK (62332-053-10)", "package_ndc": "62332-053-10", "marketing_start_date": "20160523"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (62332-053-30)", "package_ndc": "62332-053-30", "marketing_start_date": "20160523"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (62332-053-90)", "package_ndc": "62332-053-90", "marketing_start_date": "20160523"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (62332-053-91)", "package_ndc": "62332-053-91", "marketing_start_date": "20160523"}], "brand_name": "Irbesartan and Hydrochlorothiazide", "product_id": "62332-053_08cf62b6-c618-4e6a-877a-4e26ca6e91ee", "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": "62332-053", "generic_name": "Irbesartan and Hydrochlorothiazide", "labeler_name": "Alembic Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Irbesartan and Hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "25 mg/1"}, {"name": "IRBESARTAN", "strength": "300 mg/1"}], "application_number": "ANDA091370", "marketing_category": "ANDA", "marketing_start_date": "20160523", "listing_expiration_date": "20271231"}