Metolazone

Product NDC
71610-285
11-digit product format
716100285
Labeler code
71610
Product ID
71610-285_875c85ff-ca13-41b1-bc4e-ca871c3d2cd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metolazone
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076732
Marketing category
ANDA
Marketing start
2003-12-19
Substance
METOLAZONE
Active strength
2.5 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
METOLAZONE2.5 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
71610-285-09Metolazone9000 in 1 BOTTLETABLET90001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-285METOLAZONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 1 package rows20190604_71f86ee1-9e43-482b-9ad8-ec5d5576f360.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197979metOLazone 2.5 MG Oral TabletPSN71f86ee1-9e43-482b-9ad8-ec5d5576f3601
311671metOLazone 5 MG Oral TabletPSN71f86ee1-9e43-482b-9ad8-ec5d5576f3601
197979metolazone 2.5 MG Oral TabletSCD71f86ee1-9e43-482b-9ad8-ec5d5576f3601
311671metolazone 5 MG Oral TabletSCD71f86ee1-9e43-482b-9ad8-ec5d5576f3601

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-285-09716100285099000 TABLET in 1 BOTTLE (71610-285-09) 9000 tablet2019-05-310000-00-00NoNoCurrent