Metolazone

Product NDC: 71610-286
Requested package NDC: 71610-286-09
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71610-286	71610-286-09	I	Inactivated by FDA		2026-08-03

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 · 16 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	E	Excluded after deficient or non-compliant submission was not corrected	`fb8cb913e6d1…`	`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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076466-001	METOLAZONE	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19
A076466-002	METOLAZONE	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB		2003-12-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB		2003-12-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`782e0a99824c…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076466-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076466-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076466-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076466-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076466-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076466-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076466-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076466-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076466-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076466-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076466-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076466-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076466-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076466-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076466-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076466-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076466-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076466-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076466-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076466-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076466-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076466-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076466-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076466-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076466-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076466-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076466-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076466-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076466-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076466-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076466-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076466-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076466-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076466-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076466-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076466-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076466-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076466-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076466-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076466-002	AB	1	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4e48c581-6027-290d-65f0-1b09c39dc1e8	Product name	6	20250625

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71610-286-09	2023-01-30	C162847	48780-1	f386c649-f814-0266-e053-dadaa90a7c1a	Metolazone Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71610-286-09	Metolazone	9000 in 1 BOTTLE	TABLET	9000		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-286-09	EA - Each	71610-286	2d072eb3-ab77-4320-a0ad-6422ac35c21f	1	2019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-286	METOLAZONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC, 1 package rows	20190604_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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metolazone	METOLAZONE	Bryant Ranch Prepack	2125b330-eb56-4310-9806-e101eae4576c	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076466 application number: ANDA076466
Metolazone	METOLAZONE	Sandoz Inc	0b619826-2567-49d7-8972-b6da5e4467df	2025-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076466 application number: ANDA076466
Metolazone	METOLAZONE	Bryant Ranch Prepack	08cb093a-b8ec-40d9-b292-2513b488d14c	2024-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076466 application number: ANDA076466
Metolazone	METOLAZONE	Bryant Ranch Prepack	564eccca-2eba-4b6d-b6ab-1439c4c83906	2024-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076466 application number: ANDA076466
Metolazone	METOLAZONE	Bryant Ranch Prepack	8f8a79d5-5404-46f1-9974-47ae05e855d7	2023-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076466 application number: ANDA076466
Metolazone	METOLAZONE	Aphena Pharma Solutions - Tennessee, LLC	71f86ee1-9e43-482b-9ad8-ec5d5576f360	2019-06-03	Warnings, Adverse reactions	Exact identifier ndc (package): 71610-286-09 ndc (product): 71610-286 ndc11 (package): 71610028609

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TZ7V40X7VX	METOLAZONE	17560-51-9	METOLAZONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197979	metOLazone 2.5 MG Oral Tablet	PSN	71f86ee1-9e43-482b-9ad8-ec5d5576f360	1
311671	metOLazone 5 MG Oral Tablet	PSN	71f86ee1-9e43-482b-9ad8-ec5d5576f360	1
197979	metolazone 2.5 MG Oral Tablet	SCD	71f86ee1-9e43-482b-9ad8-ec5d5576f360	1
311671	metolazone 5 MG Oral Tablet	SCD	71f86ee1-9e43-482b-9ad8-ec5d5576f360	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-286-09	71610028609	9000 TABLET in 1 BOTTLE (71610-286-09)	9000 tablet	2019-05-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metolazone Tablets, USP	Aphena Pharma Solutions - Tennessee, LLC	2019-06-03	HUMAN PRESCRIPTION DRUG LABEL	1