Metolazone

Product NDC
48433-068
11-digit product format
484330068
Labeler code
48433
Product ID
48433-068_4c1322a2-fc39-f1bb-e063-6394a90a39a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metolazone
Dosage form
TABLET
Route
ORAL
Labeler
Safecor Health LLC
Application
ANDA076698
Marketing category
ANDA
Marketing start
2026-02-19
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
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
48433-068-01Metolazone1 in 1 BLISTER PACKTABLET12
48433-068-20Metolazone100 in 1 CARTONTABLET1002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197979metOLazone 2.5 MG Oral TabletPSNefa8795e-2c89-4519-b49f-13146fb9ded12
311671metOLazone 5 MG Oral TabletPSNefa8795e-2c89-4519-b49f-13146fb9ded12
197979metolazone 2.5 MG Oral TabletSCDefa8795e-2c89-4519-b49f-13146fb9ded12
311671metolazone 5 MG Oral TabletSCDefa8795e-2c89-4519-b49f-13146fb9ded12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
48433-068-01484330068011 in 1 BLISTER PACKHistorical
48433-068-2048433006820100 BLISTER PACK in 1 CARTON (48433-068-20) / 1 TABLET in 1 BLISTER PACK (48433-068-01) 100 blister pack2026-02-19NoNoHistorical