metolazone

Generic: metolazone

Labeler: method pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metolazone
Generic Name metolazone
Labeler method pharmaceuticals, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metolazone 5 mg/1

Manufacturer
Method Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 58657-741
Product ID 58657-741_4a96f40b-ed89-0892-e063-6394a90a947d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213827
Listing Expiration 2027-12-31
Marketing Start 2024-06-15

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 58657741
Hyphenated Format 58657-741

Supplemental Identifiers

RxCUI
197978 197979 311671
UPC
0358657741105 0358657741013 0358657941017 0358657942014 0358657940010 0358657742102 0358657740016 0358657742010 0358657740108
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 (58657-741-01)
  • 1000 TABLET in 1 BOTTLE (58657-741-10)
source: ndc

Packages (2)

58657-741-01 100 TABLET in 1 BOTTLE (58657-741-01) 58657-741-10 1000 TABLET in 1 BOTTLE (58657-741-10)

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": "4a96f40b-ed89-0892-e063-6394a90a947d", "openfda": {"nui": ["N0000175359", "N0000175420"], "upc": ["0358657741105", "0358657741013", "0358657941017", "0358657942014", "0358657940010", "0358657742102", "0358657740016", "0358657742010", "0358657740108"], "unii": ["TZ7V40X7VX"], "rxcui": ["197978", "197979", "311671"], "spl_set_id": ["1a8c38aa-362e-6bcc-e063-6294a90a1e05"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide-like Diuretic [EPC]"], "manufacturer_name": ["Method Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (58657-741-01)", "package_ndc": "58657-741-01", "marketing_start_date": "20240615"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (58657-741-10)", "package_ndc": "58657-741-10", "marketing_start_date": "20240615"}], "brand_name": "Metolazone", "product_id": "58657-741_4a96f40b-ed89-0892-e063-6394a90a947d", "dosage_form": "TABLET", "pharm_class": ["Increased Diuresis [PE]", "Thiazide-like Diuretic [EPC]"], "product_ndc": "58657-741", "generic_name": "Metolazone", "labeler_name": "Method Pharmaceuticals, LLC", "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": "20240615", "listing_expiration_date": "20271231"}