bisoprolol fumarate and hydrochlorothiazide (70954-413)

Drug Facts

Product Profile

Brand Name bisoprolol fumarate and hydrochlorothiazide

Generic Name bisoprolol fumarate and hydrochlorothiazide

Labeler ani pharmaceuticals, inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

bisoprolol fumarate 5 mg/1, hydrochlorothiazide 6.25 mg/1

Manufacturer

ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-413

Product ID 70954-413_394da62e-fb31-4d2b-9ca3-3f6dc2d04013

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA215562

Listing Expiration 2026-12-31

Marketing Start 2021-11-04

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 70954413

Hyphenated Format 70954-413

Supplemental Identifiers

RxCUI

854908 854916 854919

UPC

0370954413301 0370954412304 0370954414100 0370954412106

UNII

0J48LPH2TH UR59KN573L

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 bisoprolol fumarate and hydrochlorothiazide (source: ndc)

Generic Name bisoprolol fumarate and hydrochlorothiazide (source: ndc)

Application Number ANDA215562 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/1
6.25 mg/1

source: ndc

Packaging

30 TABLET in 1 BOTTLE (70954-413-10)
100 TABLET in 1 BOTTLE (70954-413-30)
500 TABLET in 1 BOTTLE (70954-413-40)

source: ndc

Packages (3)

70954-413-10 30 TABLET in 1 BOTTLE (70954-413-10) 70954-413-30 100 TABLET in 1 BOTTLE (70954-413-30) 70954-413-40 500 TABLET in 1 BOTTLE (70954-413-40)

Ingredients (2)

bisoprolol fumarate (5 mg/1) hydrochlorothiazide (6.25 mg/1)

Linked Drug Pages (1)

Bisoprolol Fumarate and Hydrochlorothiazide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "394da62e-fb31-4d2b-9ca3-3f6dc2d04013", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0370954413301", "0370954412304", "0370954414100", "0370954412106"], "unii": ["0J48LPH2TH", "UR59KN573L"], "rxcui": ["854908", "854916", "854919"], "spl_set_id": ["a26bcf78-6515-4e9f-b2dc-4aaa8ec1a82c"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (70954-413-10)", "package_ndc": "70954-413-10", "marketing_start_date": "20211104"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (70954-413-30)", "package_ndc": "70954-413-30", "marketing_start_date": "20211104"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (70954-413-40)", "package_ndc": "70954-413-40", "marketing_start_date": "20211104"}], "brand_name": "Bisoprolol Fumarate and Hydrochlorothiazide", "product_id": "70954-413_394da62e-fb31-4d2b-9ca3-3f6dc2d04013", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "70954-413", "generic_name": "Bisoprolol Fumarate and Hydrochlorothiazide", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bisoprolol Fumarate and Hydrochlorothiazide", "active_ingredients": [{"name": "BISOPROLOL FUMARATE", "strength": "5 mg/1"}, {"name": "HYDROCHLOROTHIAZIDE", "strength": "6.25 mg/1"}], "application_number": "ANDA215562", "marketing_category": "ANDA", "marketing_start_date": "20211104", "listing_expiration_date": "20261231"}