NDC 76519-1166

METOLAZONE

Metolazone

METOLAZONE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Co., Inc.. The primary component is Metolazone.

Product ID76519-1166_6856a354-e850-10cc-e053-2a91aa0a5e70
NDC76519-1166
Product TypeHuman Prescription Drug
Proprietary NameMETOLAZONE
Generic NameMetolazone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-12-08
Marketing CategoryNDA / NDA
Application NumberNDA017386
Labeler NameH.J. Harkins Co., Inc.
Substance NameMETOLAZONE
Active Ingredient Strength5 mg/1
Pharm ClassesIncreased Diuresis [PE],Thiazide-like Diuretic [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 76519-1166-0

100 TABLET in 1 VIAL (76519-1166-0)
Marketing Start Date2017-12-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76519-1166-0 [76519116600]

METOLAZONE TABLET
Marketing CategoryNDA
Application NumberNDA017386
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-08
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
METOLAZONE5 mg/1

OpenFDA Data

SPL SET ID:6856a354-e84f-10cc-e053-2a91aa0a5e70
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311671
  • Pharmacological Class

    • Increased Diuresis [PE]
    • Thiazide-like Diuretic [EPC]

    NDC Crossover Matching brand name "METOLAZONE" or generic name "Metolazone"

    NDCBrand NameGeneric Name
    0185-0055MetolazoneMetolazone
    0185-5050MetolazoneMetolazone
    0185-5600MetolazoneMetolazone
    0378-6172Metolazonemetolazone
    0378-6173Metolazonemetolazone
    0378-6174Metolazonemetolazone
    0527-2215metolazonemetolazone
    0527-2216metolazonemetolazone
    0527-2217metolazonemetolazone
    0615-6501MetolazoneMetolazone
    0615-6502MetolazoneMetolazone
    0615-7691Metolazonemetolazone
    0615-7692Metolazonemetolazone
    0904-6915metolazonemetolazone
    0904-6916metolazonemetolazone
    0904-7138METOLAZONEMETOLAZONE
    0904-7139METOLAZONEMETOLAZONE
    10135-765METOLAZONEmetolazone
    10135-766METOLAZONEmetolazone
    68151-2942MetolazoneMetolazone
    68151-2939MetolazoneMetolazone
    71610-142metolazonemetolazone
    76519-1166METOLAZONEMETOLAZONE
    43353-931MetolazoneMetolazone
    43353-999MetolazoneMetolazone
    43353-890MetolazoneMetolazone
    51079-024MetolazoneMetolazone
    51079-023MetolazoneMetolazone
    63629-7875MetolazoneMetolazone
    63739-404MetolazoneMetolazone
    65580-643metolazonemetolazone
    65580-645metolazonemetolazone
    65580-644metolazonemetolazone
    71610-286MetolazoneMetolazone
    71610-285MetolazoneMetolazone
    46708-532METOLAZONEMETOLAZONE
    62332-533METOLAZONEMETOLAZONE
    46708-533METOLAZONEMETOLAZONE
    60687-547MetolazoneMetolazone
    62332-534METOLAZONEMETOLAZONE
    60687-536MetolazoneMetolazone

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