Metolazone

Product NDC
58657-740
11-digit product format
586570740
Labeler code
58657
Product ID
58657-740_4a96f40b-ed89-0892-e063-6394a90a947d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metolazone
Dosage form
TABLET
Route
ORAL
Labeler
Method Pharmaceuticals, LLC
Application
ANDA213827
Marketing category
ANDA
Marketing start
2024-06-15
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
58657-740-01Metolazone100 in 1 BOTTLETABLET1005
58657-740-10Metolazone1000 in 1 BOTTLETABLET10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-740-01EA - Each58657-740e5a5feaa-5f5c-4ce0-8a18-1ad25aa931e712024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-740METOLAZONE TABLET [METHOD PHARMACEUTICALS, LLC]1Current NDC, 2 package rows20240617_1a8c38aa-362e-6bcc-e063-6294a90a1e05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197979metOLazone 2.5 MG Oral TabletPSN8fef500f-7855-46ed-a51e-412708505a0e101
197979metolazone 2.5 MG Oral TabletSCD8fef500f-7855-46ed-a51e-412708505a0e101
197978metOLazone 10 MG Oral TabletPSN1a8c38aa-362e-6bcc-e063-6294a90a1e055
197979metOLazone 2.5 MG Oral TabletPSN1a8c38aa-362e-6bcc-e063-6294a90a1e055
311671metOLazone 5 MG Oral TabletPSN1a8c38aa-362e-6bcc-e063-6294a90a1e055
197978metolazone 10 MG Oral TabletSCD1a8c38aa-362e-6bcc-e063-6294a90a1e055
197979metolazone 2.5 MG Oral TabletSCD1a8c38aa-362e-6bcc-e063-6294a90a1e055
311671metolazone 5 MG Oral TabletSCD1a8c38aa-362e-6bcc-e063-6294a90a1e055

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58657-740-0158657074001100 TABLET in 1 BOTTLE (58657-740-01) 100 tablet2024-06-15NoNoCurrent
58657-740-10586570740101000 TABLET in 1 BOTTLE (58657-740-10) 1000 tablet2024-06-15NoNoCurrent