metolazone

Generic: metolazone

Labeler: unichem pharmaceuticals (usa), inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metolazone
Generic Name metolazone
Labeler unichem pharmaceuticals (usa), inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metolazone 10 mg/1

Manufacturer
Unichem Pharmaceuticals (USA), Inc.

Identifiers & Regulatory

Product NDC 76385-138
Product ID 76385-138_545bb32a-23cf-4e31-a1eb-3c9636a5b592
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214799
Listing Expiration 2026-12-31
Marketing Start 2021-03-30

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 76385138
Hyphenated Format 76385-138

Supplemental Identifiers

RxCUI
197978 197979 311671
UPC
0376385136017 0376385137014 0376385138011
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 ANDA214799 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (76385-138-01)
source: ndc

Packages (1)

76385-138-01 100 TABLET in 1 BOTTLE (76385-138-01)

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": "545bb32a-23cf-4e31-a1eb-3c9636a5b592", "openfda": {"nui": ["N0000175359", "N0000175420"], "upc": ["0376385136017", "0376385137014", "0376385138011"], "unii": ["TZ7V40X7VX"], "rxcui": ["197978", "197979", "311671"], "spl_set_id": ["c6fe5426-a184-44b8-a555-621d72aa5b9f"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide-like Diuretic [EPC]"], "manufacturer_name": ["Unichem Pharmaceuticals (USA), Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (76385-138-01)", "package_ndc": "76385-138-01", "marketing_start_date": "20210330"}], "brand_name": "Metolazone", "product_id": "76385-138_545bb32a-23cf-4e31-a1eb-3c9636a5b592", "dosage_form": "TABLET", "pharm_class": ["Increased Diuresis [PE]", "Thiazide-like Diuretic [EPC]"], "product_ndc": "76385-138", "generic_name": "Metolazone", "labeler_name": "Unichem Pharmaceuticals (USA), Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metolazone", "active_ingredients": [{"name": "METOLAZONE", "strength": "10 mg/1"}], "application_number": "ANDA214799", "marketing_category": "ANDA", "marketing_start_date": "20210330", "listing_expiration_date": "20261231"}