METOLAZONE

Product NDC
72888-052
11-digit product format
728880052
Labeler code
72888
Product ID
72888-052_486ae202-9be8-35ef-e063-6294a90adb8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METOLAZONE
Dosage form
TABLET
Route
ORAL
Labeler
Advagen Pharma Limited
Application
ANDA215184
Marketing category
ANDA
Marketing start
2021-08-20
Substance
METOLAZONE
Active strength
2.5 mg/1
Pharmacologic classes
Increased Diuresis [PE], Thiazide-like Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
METOLAZONE
Listing expiration
2027-12-31

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
72888-052-01METOLAZONE100 in 1 BOTTLETABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-052-01EA - Each72888-0525d5f3b4d-0775-43dc-a461-0079ae5c815f12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-052METOLAZONE TABLET [ADVAGEN PHARMA LIMITED]2Current NDC, Legacy NDC, 1 package rows20221018_6a9c8415-e389-7a9a-73de-532cf3f57ac5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197978metOLazone 10 MG Oral TabletPSN6a9c8415-e389-7a9a-73de-532cf3f57ac53
197979metOLazone 2.5 MG Oral TabletPSN6a9c8415-e389-7a9a-73de-532cf3f57ac53
311671metOLazone 5 MG Oral TabletPSN6a9c8415-e389-7a9a-73de-532cf3f57ac53
197978metolazone 10 MG Oral TabletSCD6a9c8415-e389-7a9a-73de-532cf3f57ac53
197979metolazone 2.5 MG Oral TabletSCD6a9c8415-e389-7a9a-73de-532cf3f57ac53
311671metolazone 5 MG Oral TabletSCD6a9c8415-e389-7a9a-73de-532cf3f57ac53
197979metOLazone 2.5 MG Oral TabletPSNfc937c08-7bc0-4f97-80c9-e091e97f2f9a1
197979metolazone 2.5 MG Oral TabletSCDfc937c08-7bc0-4f97-80c9-e091e97f2f9a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72888-052-0172888005201100 TABLET in 1 BOTTLE (72888-052-01) 100 tablet2021-08-200000-00-00NoNoCurrent