bisoprolol fumarate and hydrochlorothiazide (70954-412)

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 2.5 mg/1, hydrochlorothiazide 6.25 mg/1

Manufacturer

ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-412

Product ID 70954-412_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 70954412

Hyphenated Format 70954-412

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

2.5 mg/1
6.25 mg/1

source: ndc

Packaging

30 TABLET in 1 BOTTLE (70954-412-10)
100 TABLET in 1 BOTTLE (70954-412-30)
500 TABLET in 1 BOTTLE (70954-412-40)

source: ndc

Packages (3)

70954-412-10 30 TABLET in 1 BOTTLE (70954-412-10) 70954-412-30 100 TABLET in 1 BOTTLE (70954-412-30) 70954-412-40 500 TABLET in 1 BOTTLE (70954-412-40)

Ingredients (2)

bisoprolol fumarate (2.5 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 (70954-412-10)", "package_ndc": "70954-412-10", "marketing_start_date": "20211104"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (70954-412-30)", "package_ndc": "70954-412-30", "marketing_start_date": "20211104"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (70954-412-40)", "package_ndc": "70954-412-40", "marketing_start_date": "20211104"}], "brand_name": "Bisoprolol Fumarate and Hydrochlorothiazide", "product_id": "70954-412_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": "70954-412", "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": "2.5 mg/1"}, {"name": "HYDROCHLOROTHIAZIDE", "strength": "6.25 mg/1"}], "application_number": "ANDA215562", "marketing_category": "ANDA", "marketing_start_date": "20211104", "listing_expiration_date": "20261231"}