Metolazone

Product NDC
50742-349
11-digit product format
507420349
Labeler code
50742
Product ID
50742-349_40a518ac-5d45-4c61-e063-6294a90a6ec9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metolazone
Dosage form
TABLET
Route
ORAL
Labeler
Ingenus Pharmaceuticals LLC
Application
ANDA215616
Marketing category
ANDA
Marketing start
2023-01-24
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
50742-349-01Metolazone100 in 1 BOTTLETABLET1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-349-01EA - Each50742-349a52e870d-ec8c-4835-9776-f0241e54bc6b12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-349METOLAZONE (METOLAZONE) TABLET [INGENUS PHARMACEUTICALS LLC]6Current NDC, 1 package rows20241215_1e566c10-4498-4f79-8874-4cc8c4216213.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197978metOLazone 10 MG Oral TabletPSN1e566c10-4498-4f79-8874-4cc8c42162137
197979metOLazone 2.5 MG Oral TabletPSN1e566c10-4498-4f79-8874-4cc8c42162137
311671metOLazone 5 MG Oral TabletPSN1e566c10-4498-4f79-8874-4cc8c42162137
197978metolazone 10 MG Oral TabletSCD1e566c10-4498-4f79-8874-4cc8c42162137
197979metolazone 2.5 MG Oral TabletSCD1e566c10-4498-4f79-8874-4cc8c42162137
311671metolazone 5 MG Oral TabletSCD1e566c10-4498-4f79-8874-4cc8c42162137
197979metOLazone 2.5 MG Oral TabletPSN89201e19-d0e8-4192-b2a1-150e9d2c104d1
311671metOLazone 5 MG Oral TabletPSN89201e19-d0e8-4192-b2a1-150e9d2c104d1
197979metolazone 2.5 MG Oral TabletSCD89201e19-d0e8-4192-b2a1-150e9d2c104d1
311671metolazone 5 MG Oral TabletSCD89201e19-d0e8-4192-b2a1-150e9d2c104d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50742-349-0150742034901100 TABLET in 1 BOTTLE (50742-349-01) 100 tablet2023-01-24NoNoCurrent