metolazone

Generic: metolazone

Labeler: advagen pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metolazone
Generic Name metolazone
Labeler advagen pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metolazone 5 mg/1

Manufacturer
Advagen Pharma Limited

Identifiers & Regulatory

Product NDC 72888-053
Product ID 72888-053_486ae202-9be8-35ef-e063-6294a90adb8a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215184
Listing Expiration 2027-12-31
Marketing Start 2021-08-20

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 72888053
Hyphenated Format 72888-053

Supplemental Identifiers

RxCUI
197978 197979 311671
UPC
0372888053011 0372888054018 0372888052014
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 ANDA215184 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (72888-053-01)
source: ndc

Packages (1)

72888-053-01 100 TABLET in 1 BOTTLE (72888-053-01)

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": "486ae202-9be8-35ef-e063-6294a90adb8a", "openfda": {"nui": ["N0000175359", "N0000175420"], "upc": ["0372888053011", "0372888054018", "0372888052014"], "unii": ["TZ7V40X7VX"], "rxcui": ["197978", "197979", "311671"], "spl_set_id": ["6a9c8415-e389-7a9a-73de-532cf3f57ac5"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide-like Diuretic [EPC]"], "manufacturer_name": ["Advagen Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (72888-053-01)", "package_ndc": "72888-053-01", "marketing_start_date": "20210820"}], "brand_name": "METOLAZONE", "product_id": "72888-053_486ae202-9be8-35ef-e063-6294a90adb8a", "dosage_form": "TABLET", "pharm_class": ["Increased Diuresis [PE]", "Thiazide-like Diuretic [EPC]"], "product_ndc": "72888-053", "generic_name": "METOLAZONE", "labeler_name": "Advagen Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METOLAZONE", "active_ingredients": [{"name": "METOLAZONE", "strength": "5 mg/1"}], "application_number": "ANDA215184", "marketing_category": "ANDA", "marketing_start_date": "20210820", "listing_expiration_date": "20271231"}