Metolazone

Product NDC
0378-6172
11-digit product format
003786172
Labeler code
0378
Product ID
0378-6172_80dfdc38-4f24-4670-9341-bee52a95fd49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metolazone
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA076698
Marketing category
ANDA
Marketing start
2004-01-06
Substance
METOLAZONE
Active strength
2.5 mg/1
Pharmacologic classes
Increased Diuresis [PE], Thiazide-like Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metolazone
Listing expiration
2026-12-31

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
0378-6172-01Metolazone100 in 1 BOTTLE, PLASTICTABLET10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-6172-01EA - Each0378-61726c28b452-7afa-495c-a72d-fc3b1e9ec80c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOLAZONEACTIVE INGREDIENTTZ7V40X7VXMETOLAZONE TABLET [MYLAN PHARMACEUTICALS INC.]4
METOLAZONEACTIVE MOIETYTZ7V40X7VXMETOLAZONE TABLET [MYLAN PHARMACEUTICALS INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOLAZONE TABLET [MYLAN PHARMACEUTICALS INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMETOLAZONE TABLET [MYLAN PHARMACEUTICALS INC.]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMETOLAZONE TABLET [MYLAN PHARMACEUTICALS INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8METOLAZONE TABLET [MYLAN PHARMACEUTICALS INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METOLAZONE TABLET [MYLAN PHARMACEUTICALS INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METOLAZONE TABLET [MYLAN PHARMACEUTICALS INC.]4
METOLAZONEACTIVE INGREDIENTTZ7V40X7VXMETOLAZONE TABLET [MYLAN INSTITUTIONAL INC.]2
METOLAZONEACTIVE MOIETYTZ7V40X7VXMETOLAZONE TABLET [MYLAN INSTITUTIONAL INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOLAZONE TABLET [MYLAN INSTITUTIONAL INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8METOLAZONE TABLET [MYLAN INSTITUTIONAL INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METOLAZONE TABLET [MYLAN INSTITUTIONAL INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METOLAZONE TABLET [MYLAN INSTITUTIONAL INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-6172METOLAZONE TABLET [MYLAN PHARMACEUTICALS INC.]13Current NDC, Legacy NDC, 1 package rows20241206_6639d111-eb21-4997-b964-f5c61bc088f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197978metOLazone 10 MG Oral TabletPSN6639d111-eb21-4997-b964-f5c61bc088f213
197979metOLazone 2.5 MG Oral TabletPSN6639d111-eb21-4997-b964-f5c61bc088f213
311671metOLazone 5 MG Oral TabletPSN6639d111-eb21-4997-b964-f5c61bc088f213
197978metolazone 10 MG Oral TabletSCD6639d111-eb21-4997-b964-f5c61bc088f213
197979metolazone 2.5 MG Oral TabletSCD6639d111-eb21-4997-b964-f5c61bc088f213
311671metolazone 5 MG Oral TabletSCD6639d111-eb21-4997-b964-f5c61bc088f213
197979metOLazone 2.5 MG Oral TabletPSNe5fe856e-7fd6-47fb-87f7-7c1c621f50a07
311671metOLazone 5 MG Oral TabletPSNe5fe856e-7fd6-47fb-87f7-7c1c621f50a07
197979metolazone 2.5 MG Oral TabletSCDe5fe856e-7fd6-47fb-87f7-7c1c621f50a07
311671metolazone 5 MG Oral TabletSCDe5fe856e-7fd6-47fb-87f7-7c1c621f50a07
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
197979metOLazone 2.5 MG Oral TabletPSN80500d09-e1c5-450a-9806-f4f13843229d1
311671metOLazone 5 MG Oral TabletPSN80500d09-e1c5-450a-9806-f4f13843229d1
197979metolazone 2.5 MG Oral TabletSCD80500d09-e1c5-450a-9806-f4f13843229d1
311671metolazone 5 MG Oral TabletSCD80500d09-e1c5-450a-9806-f4f13843229d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-6172-0100378617201100 TABLET in 1 BOTTLE, PLASTIC (0378-6172-01) 100 tablet2004-01-060000-00-00NoNoCurrent