FDA.reportPublic FDA data

Metolazone

Product NDC
0185-0055
11-digit product format
001850055
Labeler code
0185
Product ID
0185-0055_5d900b8f-93d6-46d0-8db9-7fe9e3791a2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metolazone
Dosage form
TABLET
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA076466
Marketing category
ANDA
Marketing start
2003-12-19
Substance
METOLAZONE
Active strength
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
METOLAZONE5 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
0185-0055-01Metolazone100 in 1 BOTTLETABLET10020
0185-0055-10Metolazone1000 in 1 BOTTLETABLET100020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0185-0055-01EA - Each0185-0055bca634e2-eccb-4142-9963-9bce24fe83b812012-07-24
0185-0055-10EA - Each0185-005502b5da3f-1a4a-4cfc-94e9-702efe67c66a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOLAZONEACTIVE INGREDIENTTZ7V40X7VXMETOLAZONE TABLET [EON LABS, INC.]16
METOLAZONEACTIVE MOIETYTZ7V40X7VXMETOLAZONE TABLET [EON LABS, INC.]16
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOLAZONE TABLET [EON LABS, INC.]16
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BMETOLAZONE TABLET [EON LABS, INC.]16
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMETOLAZONE TABLET [EON LABS, INC.]16
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMETOLAZONE TABLET [EON LABS, INC.]16
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8METOLAZONE TABLET [EON LABS, INC.]16
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METOLAZONE TABLET [EON LABS, INC.]16
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METOLAZONE TABLET [EON LABS, INC.]16
METOLAZONEACTIVE INGREDIENTTZ7V40X7VXMETOLAZONE TABLET [PHYSICIANS TOTAL CARE, INC.]2
METOLAZONEACTIVE MOIETYTZ7V40X7VXMETOLAZONE TABLET [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOLAZONE TABLET [PHYSICIANS TOTAL CARE, INC.]2
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BMETOLAZONE TABLET [PHYSICIANS TOTAL CARE, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMETOLAZONE TABLET [PHYSICIANS TOTAL CARE, INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMETOLAZONE TABLET [PHYSICIANS TOTAL CARE, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8METOLAZONE TABLET [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METOLAZONE TABLET [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METOLAZONE TABLET [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0185-0055METOLAZONE TABLET [SANDOZ INC]19Current NDC, Legacy NDC, 2 package rows20240316_0b619826-2567-49d7-8972-b6da5e4467df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311671metOLazone 5 MG Oral TabletPSN8f8a79d5-5404-46f1-9974-47ae05e855d7103
311671metolazone 5 MG Oral TabletSCD8f8a79d5-5404-46f1-9974-47ae05e855d7103
311671metOLazone 5 MG Oral TabletPSN08cb093a-b8ec-40d9-b292-2513b488d14c101
311671metolazone 5 MG Oral TabletSCD08cb093a-b8ec-40d9-b292-2513b488d14c101
311671metOLazone 5 MG Oral TabletPSN2125b330-eb56-4310-9806-e101eae4576c100
311671metolazone 5 MG Oral TabletSCD2125b330-eb56-4310-9806-e101eae4576c100
197978metOLazone 10 MG Oral TabletPSN0b619826-2567-49d7-8972-b6da5e4467df20
197979metOLazone 2.5 MG Oral TabletPSN0b619826-2567-49d7-8972-b6da5e4467df20
311671metOLazone 5 MG Oral TabletPSN0b619826-2567-49d7-8972-b6da5e4467df20
197978metolazone 10 MG Oral TabletSCD0b619826-2567-49d7-8972-b6da5e4467df20
197979metolazone 2.5 MG Oral TabletSCD0b619826-2567-49d7-8972-b6da5e4467df20
311671metolazone 5 MG Oral TabletSCD0b619826-2567-49d7-8972-b6da5e4467df20
311671metOLazone 5 MG Oral TabletPSN564eccca-2eba-4b6d-b6ab-1439c4c839064
311671metolazone 5 MG Oral TabletSCD564eccca-2eba-4b6d-b6ab-1439c4c839064
197978metOLazone 10 MG Oral TabletPSN78105e5c-5d36-426c-9f79-f2e085460b752
197979metOLazone 2.5 MG Oral TabletPSN78105e5c-5d36-426c-9f79-f2e085460b752
311671metOLazone 5 MG Oral TabletPSN78105e5c-5d36-426c-9f79-f2e085460b752
197978metolazone 10 MG Oral TabletSCD78105e5c-5d36-426c-9f79-f2e085460b752
197979metolazone 2.5 MG Oral TabletSCD78105e5c-5d36-426c-9f79-f2e085460b752
311671metolazone 5 MG Oral TabletSCD78105e5c-5d36-426c-9f79-f2e085460b752
197979metOLazone 2.5 MG Oral TabletPSN71f86ee1-9e43-482b-9ad8-ec5d5576f3601
311671metOLazone 5 MG Oral TabletPSN71f86ee1-9e43-482b-9ad8-ec5d5576f3601
197979metolazone 2.5 MG Oral TabletSCD71f86ee1-9e43-482b-9ad8-ec5d5576f3601
311671metolazone 5 MG Oral TabletSCD71f86ee1-9e43-482b-9ad8-ec5d5576f3601

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0185-0055-0100185005501100 TABLET in 1 BOTTLE (0185-0055-01) 100 tablet2003-12-190000-00-00NoNoCurrent
0185-0055-10001850055101000 TABLET in 1 BOTTLE (0185-0055-10) 1000 tablet2003-12-190000-00-00NoNoCurrent