captopril and hydrochlorothiazide (16571-828)

Drug Facts

Product Profile

Brand Name captopril and hydrochlorothiazide

Generic Name captopril and hydrochlorothiazide

Labeler rising pharma holdings, inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

captopril 25 mg/1, hydrochlorothiazide 25 mg/1

Manufacturer

Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-828

Product ID 16571-828_0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA074896

Listing Expiration 2026-12-31

Marketing Start 2023-02-14

Pharmacologic Class

Established (EPC)

thiazide diuretic [epc] angiotensin converting enzyme inhibitor [epc]

Mechanism of Action

angiotensin-converting enzyme inhibitors [moa]

Chemical Structure

thiazides [cs]

Physiologic Effect

increased diuresis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16571828

Hyphenated Format 16571-828

Supplemental Identifiers

RxCUI

197436 197437 197438 197439

UNII

0J48LPH2TH 9G64RSX1XD

NUI

N0000175359 N0000175419 M0471776 N0000175562 N0000000181

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 captopril and hydrochlorothiazide (source: ndc)

Generic Name captopril and hydrochlorothiazide (source: ndc)

Application Number ANDA074896 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

25 mg/1

source: ndc

Packaging

90 TABLET in 1 BOTTLE (16571-828-09)

source: ndc

Packages (1)

16571-828-09 90 TABLET in 1 BOTTLE (16571-828-09)

Ingredients (2)

captopril (25 mg/1) hydrochlorothiazide (25 mg/1)

Linked Drug Pages (1)

CAPTOPRIL AND HYDROCHLOROTHIAZIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000175562", "N0000000181"], "unii": ["0J48LPH2TH", "9G64RSX1XD"], "rxcui": ["197436", "197437", "197438", "197439"], "spl_set_id": ["0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]", "Angiotensin Converting Enzyme Inhibitor [EPC]"], "pharm_class_moa": ["Angiotensin-converting Enzyme Inhibitors [MoA]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (16571-828-09)", "package_ndc": "16571-828-09", "marketing_start_date": "20230214"}], "brand_name": "CAPTOPRIL AND HYDROCHLOROTHIAZIDE", "product_id": "16571-828_0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e", "dosage_form": "TABLET", "pharm_class": ["Angiotensin Converting Enzyme Inhibitor [EPC]", "Angiotensin-converting Enzyme Inhibitors [MoA]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "16571-828", "generic_name": "CAPTOPRIL AND HYDROCHLOROTHIAZIDE", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CAPTOPRIL AND HYDROCHLOROTHIAZIDE", "active_ingredients": [{"name": "CAPTOPRIL", "strength": "25 mg/1"}, {"name": "HYDROCHLOROTHIAZIDE", "strength": "25 mg/1"}], "application_number": "ANDA074896", "marketing_category": "ANDA", "marketing_start_date": "20230214", "listing_expiration_date": "20261231"}