metolazone

Generic: metolazone

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metolazone
Generic Name metolazone
Labeler micro labs limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metolazone 10 mg/1

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-418
Product ID 42571-418_47da5a45-3e85-bb97-e063-6294a90a545c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217563
Listing Expiration 2027-12-31
Marketing Start 2025-03-01

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 42571418
Hyphenated Format 42571-418

Supplemental Identifiers

RxCUI
197978 197979 311671
UPC
0342571418014 0342571416010 0342571417017
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 ANDA217563 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 CONTAINER (42571-418-01)
  • 1000 TABLET in 1 CONTAINER (42571-418-10)
source: ndc

Packages (2)

42571-418-01 100 TABLET in 1 CONTAINER (42571-418-01) 42571-418-10 1000 TABLET in 1 CONTAINER (42571-418-10)

Ingredients (1)

metolazone (10 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": "47da5a45-3e85-bb97-e063-6294a90a545c", "openfda": {"nui": ["N0000175359", "N0000175420"], "upc": ["0342571418014", "0342571416010", "0342571417017"], "unii": ["TZ7V40X7VX"], "rxcui": ["197978", "197979", "311671"], "spl_set_id": ["9ab471a1-0f71-4452-ba57-518dcc6f9f18"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide-like Diuretic [EPC]"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 CONTAINER (42571-418-01)", "package_ndc": "42571-418-01", "marketing_start_date": "20250301"}, {"sample": false, "description": "1000 TABLET in 1 CONTAINER (42571-418-10)", "package_ndc": "42571-418-10", "marketing_start_date": "20250301"}], "brand_name": "Metolazone", "product_id": "42571-418_47da5a45-3e85-bb97-e063-6294a90a545c", "dosage_form": "TABLET", "pharm_class": ["Increased Diuresis [PE]", "Thiazide-like Diuretic [EPC]"], "product_ndc": "42571-418", "generic_name": "Metolazone", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metolazone", "active_ingredients": [{"name": "METOLAZONE", "strength": "10 mg/1"}], "application_number": "ANDA217563", "marketing_category": "ANDA", "marketing_start_date": "20250301", "listing_expiration_date": "20271231"}