metolazone

Generic: metolazone

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metolazone
Generic Name metolazone
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metolazone 10 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-6174
Product ID 0378-6174_80dfdc38-4f24-4670-9341-bee52a95fd49
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076698
Listing Expiration 2026-12-31
Marketing Start 2004-10-19

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 03786174
Hyphenated Format 0378-6174

Supplemental Identifiers

RxCUI
197978 197979 311671
UPC
0303786173013 0303786172016 0303786174010
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 ANDA076698 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (0378-6174-01)
source: ndc

Packages (1)

0378-6174-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-6174-01)

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": "80dfdc38-4f24-4670-9341-bee52a95fd49", "openfda": {"nui": ["N0000175359", "N0000175420"], "upc": ["0303786173013", "0303786172016", "0303786174010"], "unii": ["TZ7V40X7VX"], "rxcui": ["197978", "197979", "311671"], "spl_set_id": ["6639d111-eb21-4997-b964-f5c61bc088f2"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide-like Diuretic [EPC]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0378-6174-01)", "package_ndc": "0378-6174-01", "marketing_start_date": "20041119"}], "brand_name": "Metolazone", "product_id": "0378-6174_80dfdc38-4f24-4670-9341-bee52a95fd49", "dosage_form": "TABLET", "pharm_class": ["Increased Diuresis [PE]", "Thiazide-like Diuretic [EPC]"], "product_ndc": "0378-6174", "generic_name": "metolazone", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metolazone", "active_ingredients": [{"name": "METOLAZONE", "strength": "10 mg/1"}], "application_number": "ANDA076698", "marketing_category": "ANDA", "marketing_start_date": "20041019", "listing_expiration_date": "20261231"}