Metolazone

Product NDC
0904-7329
11-digit product format
009047329
Labeler code
0904
Product ID
0904-7329_59f5dd79-a3de-41e1-8ae3-f3fd67fcc3e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metolazone
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA213827
Marketing category
ANDA
Marketing start
2023-08-30
Marketing end
2026-08-31
Substance
METOLAZONE
Active strength
5 mg/1
Pharmacologic classes
Increased Diuresis [PE], Thiazide-like Diuretic [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metolazone

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
0904-7329-61Metolazone1 in 1 BLISTER PACKTABLET15
0904-7329-61Metolazone100 in 1 CARTONTABLET1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7329METOLAZONE TABLET [MAJOR PHARMACEUTICALS]4Current NDC, 2 package rows20250524_8e8bbe58-0845-40d1-9831-82435f01c7be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197979metOLazone 2.5 MG Oral TabletPSN8e8bbe58-0845-40d1-9831-82435f01c7be5
311671metOLazone 5 MG Oral TabletPSN8e8bbe58-0845-40d1-9831-82435f01c7be5
197979metolazone 2.5 MG Oral TabletSCD8e8bbe58-0845-40d1-9831-82435f01c7be5
311671metolazone 5 MG Oral TabletSCD8e8bbe58-0845-40d1-9831-82435f01c7be5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7329-6100904732961100 BLISTER PACK in 1 CARTON (0904-7329-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2023-08-302026-08-31NoNoHistorical