metolazone

Generic: metolazone

Labeler: marlex pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metolazone
Generic Name metolazone
Labeler marlex pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metolazone 2.5 mg/1

Manufacturer
Marlex Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 10135-765
Product ID 10135-765_441c9c41-2125-e622-e063-6294a90adafa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216216
Listing Expiration 2026-12-31
Marketing Start 2022-12-01

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 10135765
Hyphenated Format 10135-765

Supplemental Identifiers

RxCUI
197978 197979 311671
UNII
TZ7V40X7VX
NUI
N0000175359 N0000175420

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 metolazone (source: ndc)
Generic Name metolazone (source: ndc)
Application Number ANDA216216 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (10135-765-01)
  • 1000 TABLET in 1 BOTTLE (10135-765-10)
source: ndc

Packages (2)

10135-765-01 100 TABLET in 1 BOTTLE (10135-765-01) 10135-765-10 1000 TABLET in 1 BOTTLE (10135-765-10)

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": "441c9c41-2125-e622-e063-6294a90adafa", "openfda": {"nui": ["N0000175359", "N0000175420"], "unii": ["TZ7V40X7VX"], "rxcui": ["197978", "197979", "311671"], "spl_set_id": ["efa5244a-9cdf-a806-e053-2a95a90a912e"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide-like Diuretic [EPC]"], "manufacturer_name": ["Marlex Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (10135-765-01)", "package_ndc": "10135-765-01", "marketing_start_date": "20221201"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (10135-765-10)", "package_ndc": "10135-765-10", "marketing_start_date": "20221201"}], "brand_name": "METOLAZONE", "product_id": "10135-765_441c9c41-2125-e622-e063-6294a90adafa", "dosage_form": "TABLET", "pharm_class": ["Increased Diuresis [PE]", "Thiazide-like Diuretic [EPC]"], "product_ndc": "10135-765", "generic_name": "metolazone", "labeler_name": "Marlex Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METOLAZONE", "active_ingredients": [{"name": "METOLAZONE", "strength": "2.5 mg/1"}], "application_number": "ANDA216216", "marketing_category": "ANDA", "marketing_start_date": "20221201", "listing_expiration_date": "20261231"}