Metolazone

Product NDC
71610-286
11-digit product format
716100286
Labeler code
71610
Product ID
71610-286_875c85ff-ca13-41b1-bc4e-ca871c3d2cd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metolazone
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076466
Marketing category
ANDA
Marketing start
2003-12-19
Marketing end
0000-00-00
Substance
METOLAZONE
Active strength
5 mg/1
Pharmacologic classes
Increased Diuresis [PE],Thiazide-like Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct71610-286IInactivated by FDA2026-08-03
excluded packagepackage71610-28671610-286-09IInactivated by FDA2026-08-03

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 · 32 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71610-286-09IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71610-286-09IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71610-286-09IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71610-286-09IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71610-286-09IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71610-286-09IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71610-286-09IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71610-286-09IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71610-286-09IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71610-286-09IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71610-286-09IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71610-286-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71610-286-09IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71610-286-09IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71610-286-09IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductEExcluded after deficient or non-compliant submission was not correctedfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage71610-286-09EExcluded after deficient or non-compliant submission was not correctedfb8cb913e6d1…eb8c232b6be0…

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076466-001METOLAZONEMETOLAZONE5MGTABLET / ORALABRS2003-12-19
A076466-002METOLAZONEMETOLAZONE10MGTABLET / ORALABRS2003-12-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A076466-001AB
A076466-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076466-001METOLAZONE5MGTABLET / ORALABRS2003-12-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076466-002METOLAZONE10MGTABLET / ORALABRS2003-12-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076466-001METOLAZONE5MGTABLET / ORALABRS2003-12-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076466-002METOLAZONE10MGTABLET / ORALABRS2003-12-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A076466-001METOLAZONE5MGTABLET / ORALABRS2003-12-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076466-002METOLAZONE10MGTABLET / ORALABRS2003-12-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076466-001METOLAZONE5MGTABLET / ORALABRS2003-12-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076466-002METOLAZONE10MGTABLET / ORALABRS2003-12-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076466-001METOLAZONE5MGTABLET / ORALABRS2003-12-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076466-002METOLAZONE10MGTABLET / ORALABRS2003-12-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076466-001METOLAZONE5MGTABLET / ORALABRS2003-12-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076466-002METOLAZONE10MGTABLET / ORALABRS2003-12-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076466-001METOLAZONE5MGTABLET / ORALABRS2003-12-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076466-002METOLAZONE10MGTABLET / ORALABRS2003-12-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076466-001METOLAZONE5MGTABLET / ORALABRS2003-12-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076466-002METOLAZONE10MGTABLET / ORALABRS2003-12-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076466-001METOLAZONE5MGTABLET / ORALABRS2003-12-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076466-002METOLAZONE10MGTABLET / ORALABRS2003-12-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076466-001METOLAZONE5MGTABLET / ORALABRS2003-12-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A076466-002METOLAZONE10MGTABLET / ORALABRS2003-12-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076466-001METOLAZONE5MGTABLET / ORALABRS2003-12-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076466-002METOLAZONE10MGTABLET / ORALABRS2003-12-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076466-001METOLAZONE5MGTABLET / ORALABRS2003-12-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076466-002METOLAZONE10MGTABLET / ORALABRS2003-12-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076466-001METOLAZONE5MGTABLET / ORALABRS2003-12-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076466-002METOLAZONE10MGTABLET / ORALABRS2003-12-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076466-001METOLAZONE5MGTABLET / ORALABRS2003-12-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076466-002METOLAZONE10MGTABLET / ORALABRS2003-12-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076466-001METOLAZONE5MGTABLET / ORALABRS2003-12-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076466-002METOLAZONE10MGTABLET / ORALABRS2003-12-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076466-001METOLAZONE5MGTABLET / ORALABRS2003-12-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076466-002METOLAZONE10MGTABLET / ORALABRS2003-12-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076466-001METOLAZONE5MGTABLET / ORALABRS2003-12-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076466-002METOLAZONE10MGTABLET / ORALABRS2003-12-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076466-001METOLAZONE5MGTABLET / ORALAB2003-12-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076466-002METOLAZONE10MGTABLET / ORALAB2003-12-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076466-001METOLAZONE5MGTABLET / ORALABRS2003-12-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076466-002METOLAZONE10MGTABLET / ORALABRS2003-12-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076466-001METOLAZONE5MGTABLET / ORALABRS2003-12-19782e0a99824c…
2021-12-28 21:50 UTC2021-12A076466-002METOLAZONE10MGTABLET / ORALABRS2003-12-19782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076466-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076466-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076466-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076466-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076466-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076466-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076466-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076466-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076466-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076466-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076466-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076466-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076466-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076466-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076466-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076466-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076466-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076466-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076466-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076466-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076466-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076466-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076466-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076466-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076466-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076466-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076466-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076466-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076466-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076466-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076466-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076466-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076466-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076466-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076466-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076466-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076466-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076466-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076466-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A076466-002AB1782e0a99824c…

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
71610-286-092023-01-30C16284748780-1f386c649-f814-0266-e053-dadaa90a7c1aMetolazone Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-286-09Metolazone9000 in 1 BOTTLETABLET90001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-286-09EA - Each71610-2862d072eb3-ab77-4320-a0ad-6422ac35c21f12019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-286METOLAZONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 1 package rows20190604_71f86ee1-9e43-482b-9ad8-ec5d5576f360.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetolazoneMETOLAZONEBryant Ranch Prepack2125b330-eb56-4310-9806-e101eae4576c2025-10-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076466
application number: ANDA076466
MetolazoneMETOLAZONESandoz Inc0b619826-2567-49d7-8972-b6da5e4467df2025-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076466
application number: ANDA076466
MetolazoneMETOLAZONEBryant Ranch Prepack08cb093a-b8ec-40d9-b292-2513b488d14c2024-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076466
application number: ANDA076466
MetolazoneMETOLAZONEBryant Ranch Prepack564eccca-2eba-4b6d-b6ab-1439c4c839062024-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076466
application number: ANDA076466
MetolazoneMETOLAZONEBryant Ranch Prepack8f8a79d5-5404-46f1-9974-47ae05e855d72023-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076466
application number: ANDA076466
MetolazoneMETOLAZONEAphena Pharma Solutions - Tennessee, LLC71f86ee1-9e43-482b-9ad8-ec5d5576f3602019-06-03Warnings, Adverse reactionsExact identifier
ndc (product): 71610-286

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
71610-286-09716100286099000 TABLET in 1 BOTTLE (71610-286-09) 9000 tablet2019-05-310000-00-00NoNoCurrent