Metolazone

Product NDC
69292-566
11-digit product format
692920566
Labeler code
69292
Product ID
69292-566_4e6cbb9b-9a10-2771-e063-6394a90aef38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metolazone
Dosage form
TABLET
Route
ORAL
Labeler
Amici Pharma, Inc
Application
ANDA213827
Marketing category
ANDA
Marketing start
2021-05-15
Substance
METOLAZONE
Active strength
10 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
METOLAZONE10 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
69292-566-01Metolazone100 in 1 BOTTLETABLET1004
69292-566-10Metolazone1000 in 1 BOTTLETABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69292-566-01EA - Each69292-5663868b002-d899-4134-8674-d0a44c3cd58d12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69292-566METOLAZONE TABLET [AMICI PHARMA, INC]3Current NDC, Legacy NDC, 2 package rows20250315_cbfa3d5c-cce9-4afa-b064-06f1e1041eac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197978metOLazone 10 MG Oral TabletPSNc67c00c9-2c2c-6223-e053-2995a90a72914
197978metOLazone 10 MG Oral TabletPSNcbfa3d5c-cce9-4afa-b064-06f1e1041eac4
197979metOLazone 2.5 MG Oral TabletPSNc67c00c9-2c2c-6223-e053-2995a90a72914
197979metOLazone 2.5 MG Oral TabletPSNcbfa3d5c-cce9-4afa-b064-06f1e1041eac4
311671metOLazone 5 MG Oral TabletPSNc67c00c9-2c2c-6223-e053-2995a90a72914
311671metOLazone 5 MG Oral TabletPSNcbfa3d5c-cce9-4afa-b064-06f1e1041eac4
197978metolazone 10 MG Oral TabletSCDc67c00c9-2c2c-6223-e053-2995a90a72914
197978metolazone 10 MG Oral TabletSCDcbfa3d5c-cce9-4afa-b064-06f1e1041eac4
197979metolazone 2.5 MG Oral TabletSCDc67c00c9-2c2c-6223-e053-2995a90a72914
197979metolazone 2.5 MG Oral TabletSCDcbfa3d5c-cce9-4afa-b064-06f1e1041eac4
311671metolazone 5 MG Oral TabletSCDc67c00c9-2c2c-6223-e053-2995a90a72914
311671metolazone 5 MG Oral TabletSCDcbfa3d5c-cce9-4afa-b064-06f1e1041eac4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69292-566-0169292056601100 TABLET in 1 BOTTLE (69292-566-01) 100 tablet2021-05-150000-00-00NoNoCurrent
69292-566-10692920566101000 TABLET in 1 BOTTLE (69292-566-10) 1000 tablet2021-05-150000-00-00NoNoCurrent