metolazone

Generic: metolazone

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metolazone
Generic Name metolazone
Labeler sandoz inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metolazone 2.5 mg/1

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0185-5050
Product ID 0185-5050_5d900b8f-93d6-46d0-8db9-7fe9e3791a2f
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 01855050
Hyphenated Format 0185-5050

Supplemental Identifiers

RxCUI
197978 197979 311671
UPC
0301855600019 0301855050012 0301850055012
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 ANDA076732 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0185-5050-01)
  • 1000 TABLET in 1 BOTTLE (0185-5050-10)
source: ndc

Packages (2)

Ingredients (1)

metolazone (2.5 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "5d900b8f-93d6-46d0-8db9-7fe9e3791a2f", "openfda": {"nui": ["N0000175359", "N0000175420"], "upc": ["0301855600019", "0301855050012", "0301850055012"], "unii": ["TZ7V40X7VX"], "rxcui": ["197978", "197979", "311671"], "spl_set_id": ["0b619826-2567-49d7-8972-b6da5e4467df"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide-like Diuretic [EPC]"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0185-5050-01)", "package_ndc": "0185-5050-01", "marketing_start_date": "20031219"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (0185-5050-10)", "package_ndc": "0185-5050-10", "marketing_start_date": "20031219"}], "brand_name": "Metolazone", "product_id": "0185-5050_5d900b8f-93d6-46d0-8db9-7fe9e3791a2f", "dosage_form": "TABLET", "pharm_class": ["Increased Diuresis [PE]", "Thiazide-like Diuretic [EPC]"], "product_ndc": "0185-5050", "generic_name": "Metolazone", "labeler_name": "Sandoz Inc", "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"}