METOLAZONE

Product NDC
62332-532
11-digit product format
623320532
Labeler code
62332
Product ID
62332-532_4e197913-c368-474d-a147-e9ade3021e37
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METOLAZONE
Dosage form
TABLET
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA213251
Marketing category
ANDA
Marketing start
2020-12-02
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
Rxcui197978, 197979, 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
62332-532-31METOLAZONE100 in 1 BOTTLETABLET1009
62332-532-91METOLAZONE1000 in 1 BOTTLETABLET10009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-532METOLAZONE TABLET [ALEMBIC PHARMACEUTICALS INC.]9Current NDC, Legacy NDC, 2 package rows20240523_a84dbb37-648e-42d4-8688-ac39599284f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197978metOLazone 10 MG Oral TabletPSNa84dbb37-648e-42d4-8688-ac39599284f09
197979metOLazone 2.5 MG Oral TabletPSNa84dbb37-648e-42d4-8688-ac39599284f09
311671metOLazone 5 MG Oral TabletPSNa84dbb37-648e-42d4-8688-ac39599284f09
197978metolazone 10 MG Oral TabletSCDa84dbb37-648e-42d4-8688-ac39599284f09
197979metolazone 2.5 MG Oral TabletSCDa84dbb37-648e-42d4-8688-ac39599284f09
311671metolazone 5 MG Oral TabletSCDa84dbb37-648e-42d4-8688-ac39599284f09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-532-3162332053231100 TABLET in 1 BOTTLE (62332-532-31) 100 tablet2020-12-020000-00-00NoNoCurrent
62332-532-91623320532911000 TABLET in 1 BOTTLE (62332-532-91) 1000 tablet2020-12-020000-00-00NoNoCurrent