metolazone

Product NDC
65580-645
11-digit product format
655800645
Labeler code
65580
Product ID
65580-645_5716d764-3691-4ebc-8e42-dbcac00f48a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metolazone
Dosage form
TABLET
Route
ORAL
Labeler
Upstate Pharma, LLC
Application
NDA017386
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1973-11-27
Marketing end
0000-00-00
Substance
METOLAZONE
Active strength
10 mg/1
Pharmacologic classes
Increased Diuresis [PE],Thiazide-like Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct65580-645IInactivated by FDA2026-08-10
excluded packagepackage65580-64565580-645-71IInactivated by FDA2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65580-645-71d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65580-645-71f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65580-645-712ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage65580-645-71a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage65580-645-71cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage65580-645-71cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage65580-645-71302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage65580-645-71ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage65580-645-710efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage65580-645-71ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage65580-645-71367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage65580-645-71557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage65580-645-718af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage65580-645-71834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage65580-645-711332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage65580-645-71fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage65580-645-7186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage65580-645-71bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage65580-645-718dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage65580-645-71e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage65580-645-719bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017386-001ZAROXOLYNMETOLAZONE2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982
N017386-002ZAROXOLYNMETOLAZONE5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982
N017386-003ZAROXOLYNMETOLAZONE10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N017386-001ZAROXOLYN2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017386-002ZAROXOLYN5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017386-003ZAROXOLYN10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017386-001ZAROXOLYN2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017386-002ZAROXOLYN5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017386-003ZAROXOLYN10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N017386-001ZAROXOLYN2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017386-002ZAROXOLYN5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017386-003ZAROXOLYN10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017386-001ZAROXOLYN2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017386-002ZAROXOLYN5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017386-003ZAROXOLYN10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017386-001ZAROXOLYN2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017386-002ZAROXOLYN5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017386-003ZAROXOLYN10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017386-001ZAROXOLYN2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017386-002ZAROXOLYN5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017386-003ZAROXOLYN10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017386-001ZAROXOLYN2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017386-002ZAROXOLYN5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017386-003ZAROXOLYN10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017386-001ZAROXOLYN2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017386-002ZAROXOLYN5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017386-003ZAROXOLYN10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017386-001ZAROXOLYN2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017386-002ZAROXOLYN5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017386-003ZAROXOLYN10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017386-001ZAROXOLYN2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N017386-002ZAROXOLYN5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N017386-003ZAROXOLYN10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017386-001ZAROXOLYN2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017386-002ZAROXOLYN5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017386-003ZAROXOLYN10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017386-001ZAROXOLYN2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017386-002ZAROXOLYN5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017386-003ZAROXOLYN10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017386-001ZAROXOLYN2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017386-002ZAROXOLYN5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017386-003ZAROXOLYN10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017386-001ZAROXOLYN2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19828072bd15b7f6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N017386-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N017386-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N017386-003AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017386-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017386-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017386-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N017386-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N017386-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N017386-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017386-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N017386-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N017386-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017386-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N017386-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N017386-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017386-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N017386-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N017386-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N017386-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N017386-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N017386-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N017386-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N017386-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N017386-003AB1ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4e48c581-6027-290d-65f0-1b09c39dc1e8Product name620250625

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65580-645-712020-01-31C16284748780-19d75b9cf-eefd-f424-e053-dadaa90a57ceMetolazone Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65580-645-71metolazone100 in 1 BOTTLE, PLASTICTABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65580-645-71EA - Each65580-645b41bb479-3b8a-4c6a-b7aa-c8ae98721e4412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
metolazoneACTIVE INGREDIENTTZ7V40X7VXMETOLAZONE TABLET [UPSTATE PHARMA, LLC]3
metolazoneACTIVE MOIETYTZ7V40X7VXMETOLAZONE TABLET [UPSTATE PHARMA, LLC]3
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UMETOLAZONE TABLET [UPSTATE PHARMA, LLC]3
D&C Red No. 33INACTIVE INGREDIENT9DBA0SBB0LMETOLAZONE TABLET [UPSTATE PHARMA, LLC]3
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKMETOLAZONE TABLET [UPSTATE PHARMA, LLC]3
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8METOLAZONE TABLET [UPSTATE PHARMA, LLC]3
magnesium stearateINACTIVE INGREDIENT70097M6I30METOLAZONE TABLET [UPSTATE PHARMA, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65580-645METOLAZONE TABLET [UPSTATE PHARMA, LLC]3Legacy NDC, 1 package rows20150611_f45f5353-38a3-42c6-bffc-96bea8dcf818.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197978metOLazone 10 MG Oral TabletPSNf45f5353-38a3-42c6-bffc-96bea8dcf8183
197979metOLazone 2.5 MG Oral TabletPSNf45f5353-38a3-42c6-bffc-96bea8dcf8183
311671metOLazone 5 MG Oral TabletPSNf45f5353-38a3-42c6-bffc-96bea8dcf8183
197978metolazone 10 MG Oral TabletSCDf45f5353-38a3-42c6-bffc-96bea8dcf8183
197979metolazone 2.5 MG Oral TabletSCDf45f5353-38a3-42c6-bffc-96bea8dcf8183
311671metolazone 5 MG Oral TabletSCDf45f5353-38a3-42c6-bffc-96bea8dcf8183

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
65580-645-7165580064571100 in 1 BOTTLE, PLASTICHistorical