Metolazone

Product NDC
43353-931
11-digit product format
433530931
Labeler code
43353
Product ID
43353-931_5e3b0779-f81b-410e-820e-5cd76dad6bf5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metolazone
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076698
Marketing category
ANDA
Marketing start
2004-10-19
Substance
METOLAZONE
Active strength
5 mg/1
Pharmacologic classes
Increased Diuresis [PE], Thiazide-like Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metolazone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOLAZONE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTZ7V40X7VX
Rxcui197979, 311671

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4e48c581-6027-290d-65f0-1b09c39dc1e8Product name620250625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-931-09Metolazone9000 in 1 BOTTLE, PLASTICTABLET90001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-931-09EA - Each43353-931decde541-4dd0-445d-9b11-6122d1110db012018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-931METOLAZONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 1 package rows20171216_80500d09-e1c5-450a-9806-f4f13843229d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197979metOLazone 2.5 MG Oral TabletPSN80500d09-e1c5-450a-9806-f4f13843229d1
311671metOLazone 5 MG Oral TabletPSN80500d09-e1c5-450a-9806-f4f13843229d1
197979metolazone 2.5 MG Oral TabletSCD80500d09-e1c5-450a-9806-f4f13843229d1
311671metolazone 5 MG Oral TabletSCD80500d09-e1c5-450a-9806-f4f13843229d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-931-09433530931099000 TABLET in 1 BOTTLE, PLASTIC (43353-931-09) 9000 tablet2014-04-240000-00-00NoNoCurrent