metolazone

Generic: metolazone

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metolazone
Generic Name metolazone
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metolazone 2.5 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-285
Product ID 71610-285_875c85ff-ca13-41b1-bc4e-ca871c3d2cd1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076732
Listing Expiration 2026-12-31
Marketing Start 2003-12-19

Pharmacologic Class

Established (EPC)
thiazide-like diuretic [epc]
Physiologic Effect
increased diuresis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610285
Hyphenated Format 71610-285

Supplemental Identifiers

RxCUI
197979 311671
UNII
TZ7V40X7VX
NUI
N0000175359 N0000175420

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 metolazone (source: ndc)
Generic Name metolazone (source: ndc)
Application Number ANDA076732 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 9000 TABLET in 1 BOTTLE (71610-285-09)
source: ndc

Packages (1)

71610-285-09 9000 TABLET in 1 BOTTLE (71610-285-09)

Ingredients (1)

metolazone (2.5 mg/1)

Linked Drug Pages (1)

Metolazone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "875c85ff-ca13-41b1-bc4e-ca871c3d2cd1", "openfda": {"nui": ["N0000175359", "N0000175420"], "unii": ["TZ7V40X7VX"], "rxcui": ["197979", "311671"], "spl_set_id": ["71f86ee1-9e43-482b-9ad8-ec5d5576f360"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide-like Diuretic [EPC]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "9000 TABLET in 1 BOTTLE (71610-285-09)", "package_ndc": "71610-285-09", "marketing_start_date": "20190531"}], "brand_name": "Metolazone", "product_id": "71610-285_875c85ff-ca13-41b1-bc4e-ca871c3d2cd1", "dosage_form": "TABLET", "pharm_class": ["Increased Diuresis [PE]", "Thiazide-like Diuretic [EPC]"], "product_ndc": "71610-285", "generic_name": "Metolazone", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metolazone", "active_ingredients": [{"name": "METOLAZONE", "strength": "2.5 mg/1"}], "application_number": "ANDA076732", "marketing_category": "ANDA", "marketing_start_date": "20031219", "listing_expiration_date": "20261231"}