metolazone

Generic: metolazone

Labeler: amici pharma, inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metolazone
Generic Name metolazone
Labeler amici pharma, inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metolazone 5 mg/1

Manufacturer
Amici Pharma, Inc

Identifiers & Regulatory

Product NDC 69292-564
Product ID 69292-564_276c09e7-fb13-4b25-b4de-b032f1cd1778
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213827
Listing Expiration 2026-12-31
Marketing Start 2021-05-15

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 69292564
Hyphenated Format 69292-564

Supplemental Identifiers

RxCUI
197978 197979 311671
UPC
0369292566015 0369292564011 0369292562017
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 ANDA213827 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (69292-564-01)
  • 1000 TABLET in 1 BOTTLE (69292-564-10)
source: ndc

Packages (2)

69292-564-01 100 TABLET in 1 BOTTLE (69292-564-01) 69292-564-10 1000 TABLET in 1 BOTTLE (69292-564-10)

Ingredients (1)

metolazone (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": "276c09e7-fb13-4b25-b4de-b032f1cd1778", "openfda": {"nui": ["N0000175359", "N0000175420"], "upc": ["0369292566015", "0369292564011", "0369292562017"], "unii": ["TZ7V40X7VX"], "rxcui": ["197978", "197979", "311671"], "spl_set_id": ["cbfa3d5c-cce9-4afa-b064-06f1e1041eac"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide-like Diuretic [EPC]"], "manufacturer_name": ["Amici Pharma, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (69292-564-01)", "package_ndc": "69292-564-01", "marketing_start_date": "20210515"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (69292-564-10)", "package_ndc": "69292-564-10", "marketing_start_date": "20210515"}], "brand_name": "Metolazone", "product_id": "69292-564_276c09e7-fb13-4b25-b4de-b032f1cd1778", "dosage_form": "TABLET", "pharm_class": ["Increased Diuresis [PE]", "Thiazide-like Diuretic [EPC]"], "product_ndc": "69292-564", "generic_name": "Metolazone", "labeler_name": "Amici Pharma, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metolazone", "active_ingredients": [{"name": "METOLAZONE", "strength": "5 mg/1"}], "application_number": "ANDA213827", "marketing_category": "ANDA", "marketing_start_date": "20210515", "listing_expiration_date": "20261231"}