captopril and hydrochlorothiazide

Generic: captopril and hydrochlorothiazide

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

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 15 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-827
Product ID 16571-827_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 16571827
Hyphenated Format 16571-827

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
  • 15 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (16571-827-09)
source: ndc

Packages (1)

16571-827-09 90 TABLET in 1 BOTTLE (16571-827-09)

Ingredients (2)

captopril (25 mg/1) hydrochlorothiazide (15 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 (16571-827-09)", "package_ndc": "16571-827-09", "marketing_start_date": "20230214"}], "brand_name": "CAPTOPRIL AND HYDROCHLOROTHIAZIDE", "product_id": "16571-827_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": "16571-827", "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": "15 mg/1"}], "application_number": "ANDA074896", "marketing_category": "ANDA", "marketing_start_date": "20230214", "listing_expiration_date": "20261231"}