Metolazone

Product NDC: 69292-564
11-digit product format: 692920564
Labeler code: 69292
Product ID: 69292-564_4e6cbb9b-9a10-2771-e063-6394a90aef38
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metolazone
Dosage form: TABLET
Route: ORAL
Labeler: Amici Pharma, Inc
Application: ANDA213827
Marketing category: ANDA
Marketing start: 2021-05-15
Substance: METOLAZONE
Active strength: 5 mg/1
Pharmacologic classes: Increased Diuresis [PE], Thiazide-like Diuretic [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A213827-001	METOLAZONE	METOLAZONE	2.5MG	TABLET / ORAL	AB	2021-03-30
A213827-002	METOLAZONE	METOLAZONE	5MG	TABLET / ORAL	AB	2021-03-30
A213827-003	METOLAZONE	METOLAZONE	10MG	TABLET / ORAL	AB	2021-03-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A213827-001	AB
A213827-002	AB
A213827-003	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 · 102 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213827-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2021-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213827-002	METOLAZONE	5MG	TABLET / ORAL	AB	2021-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213827-003	METOLAZONE	10MG	TABLET / ORAL	AB	2021-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213827-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2021-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213827-002	METOLAZONE	5MG	TABLET / ORAL	AB	2021-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213827-003	METOLAZONE	10MG	TABLET / ORAL	AB	2021-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213827-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2021-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213827-002	METOLAZONE	5MG	TABLET / ORAL	AB	2021-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213827-003	METOLAZONE	10MG	TABLET / ORAL	AB	2021-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213827-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2021-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213827-002	METOLAZONE	5MG	TABLET / ORAL	AB	2021-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213827-003	METOLAZONE	10MG	TABLET / ORAL	AB	2021-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213827-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2021-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213827-002	METOLAZONE	5MG	TABLET / ORAL	AB	2021-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213827-003	METOLAZONE	10MG	TABLET / ORAL	AB	2021-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213827-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2021-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213827-002	METOLAZONE	5MG	TABLET / ORAL	AB	2021-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213827-003	METOLAZONE	10MG	TABLET / ORAL	AB	2021-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213827-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2021-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213827-002	METOLAZONE	5MG	TABLET / ORAL	AB	2021-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213827-003	METOLAZONE	10MG	TABLET / ORAL	AB	2021-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213827-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2021-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213827-002	METOLAZONE	5MG	TABLET / ORAL	AB	2021-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213827-003	METOLAZONE	10MG	TABLET / ORAL	AB	2021-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213827-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2021-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213827-002	METOLAZONE	5MG	TABLET / ORAL	AB	2021-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213827-003	METOLAZONE	10MG	TABLET / ORAL	AB	2021-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213827-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2021-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213827-002	METOLAZONE	5MG	TABLET / ORAL	AB	2021-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213827-003	METOLAZONE	10MG	TABLET / ORAL	AB	2021-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213827-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2021-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213827-002	METOLAZONE	5MG	TABLET / ORAL	AB	2021-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213827-003	METOLAZONE	10MG	TABLET / ORAL	AB	2021-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213827-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2021-03-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213827-002	METOLAZONE	5MG	TABLET / ORAL	AB	2021-03-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213827-003	METOLAZONE	10MG	TABLET / ORAL	AB	2021-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213827-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2021-03-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213827-002	METOLAZONE	5MG	TABLET / ORAL	AB	2021-03-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213827-003	METOLAZONE	10MG	TABLET / ORAL	AB	2021-03-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213827-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2021-03-30	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 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	A213827-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213827-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213827-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213827-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213827-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213827-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213827-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213827-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213827-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213827-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213827-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213827-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213827-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213827-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213827-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213827-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213827-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213827-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213827-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213827-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213827-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213827-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213827-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213827-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213827-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213827-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213827-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213827-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213827-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213827-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213827-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213827-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213827-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213827-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213827-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213827-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213827-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213827-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213827-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213827-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Metolazone
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METOLAZONE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TZ7V40X7VX	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197978	Internal RxNorm lookup
197979	Internal RxNorm lookup
311671	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
cbfa3d5c-cce9-4afa-b064-06f1e1041eac	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69292-564-01	Metolazone	100 in 1 BOTTLE	TABLET	100		4
69292-564-10	Metolazone	1000 in 1 BOTTLE	TABLET	1000		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69292-564-01	EA - Each	69292-564	48346f69-edf3-4230-9a15-9befd174374f	1	2021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69292-564	METOLAZONE TABLET [AMICI PHARMA, INC]	3	Current NDC, Legacy NDC, 2 package rows	20250315_cbfa3d5c-cce9-4afa-b064-06f1e1041eac.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metolazone	METOLAZONE	Bryant Ranch Prepack	27ab833e-b809-4a80-b7fc-b3599f1751d3	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213827 application number: ANDA213827
Metolazone	METOLAZONE	Bryant Ranch Prepack	8fef500f-7855-46ed-a51e-412708505a0e	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213827 application number: ANDA213827
Metolazone	METOLAZONE	Golden State Medical Supply, Inc.	c67c00c9-2c2c-6223-e053-2995a90a7291	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213827 application number: ANDA213827
Metolazone	METOLAZONE	Amici Pharma, Inc	cbfa3d5c-cce9-4afa-b064-06f1e1041eac	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213827 application number: ANDA213827 ndc (product): 69292-564
Metolazone	METOLAZONE	Bryant Ranch Prepack	7df08bbb-0ab8-485c-8994-48ecadd096f1	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213827 application number: ANDA213827
Metolazone	METOLAZONE	Method Pharmaceuticals, LLC	1a8c38aa-362e-6bcc-e063-6294a90a1e05	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213827 application number: ANDA213827
Metolazone	METOLAZONE	Major Pharmaceuticals	8e8bbe58-0845-40d1-9831-82435f01c7be	2025-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213827 application number: ANDA213827
Metolazone	METOLAZONE	Bryant Ranch Prepack	3be4e158-e486-44db-9be7-dc72fdc2dbc7	2025-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213827 application number: ANDA213827
Metolazone	METOLAZONE	American Health Packaging	0bc97c74-533a-40a6-bcaf-5374890c5846	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213827 application number: ANDA213827
Metolazone	METOLAZONE	A-S Medication Solutions	c9e51766-8f1d-4258-9f40-1d394e2de04c	2023-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213827 application number: ANDA213827

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
311671	metOLazone 5 MG Oral Tablet	PSN	3be4e158-e486-44db-9be7-dc72fdc2dbc7	102
311671	metolazone 5 MG Oral Tablet	SCD	3be4e158-e486-44db-9be7-dc72fdc2dbc7	102
197979	metOLazone 2.5 MG Oral Tablet	PSN	8e8bbe58-0845-40d1-9831-82435f01c7be	5
311671	metOLazone 5 MG Oral Tablet	PSN	8e8bbe58-0845-40d1-9831-82435f01c7be	5
197979	metolazone 2.5 MG Oral Tablet	SCD	8e8bbe58-0845-40d1-9831-82435f01c7be	5
311671	metolazone 5 MG Oral Tablet	SCD	8e8bbe58-0845-40d1-9831-82435f01c7be	5
197978	metOLazone 10 MG Oral Tablet	PSN	c67c00c9-2c2c-6223-e053-2995a90a7291	4
197978	metOLazone 10 MG Oral Tablet	PSN	cbfa3d5c-cce9-4afa-b064-06f1e1041eac	4
197979	metOLazone 2.5 MG Oral Tablet	PSN	cbfa3d5c-cce9-4afa-b064-06f1e1041eac	4
197979	metOLazone 2.5 MG Oral Tablet	PSN	c67c00c9-2c2c-6223-e053-2995a90a7291	4
311671	metOLazone 5 MG Oral Tablet	PSN	cbfa3d5c-cce9-4afa-b064-06f1e1041eac	4
311671	metOLazone 5 MG Oral Tablet	PSN	c67c00c9-2c2c-6223-e053-2995a90a7291	4
197978	metolazone 10 MG Oral Tablet	SCD	cbfa3d5c-cce9-4afa-b064-06f1e1041eac	4
197978	metolazone 10 MG Oral Tablet	SCD	c67c00c9-2c2c-6223-e053-2995a90a7291	4
197979	metolazone 2.5 MG Oral Tablet	SCD	cbfa3d5c-cce9-4afa-b064-06f1e1041eac	4
197979	metolazone 2.5 MG Oral Tablet	SCD	c67c00c9-2c2c-6223-e053-2995a90a7291	4
311671	metolazone 5 MG Oral Tablet	SCD	cbfa3d5c-cce9-4afa-b064-06f1e1041eac	4
311671	metolazone 5 MG Oral Tablet	SCD	c67c00c9-2c2c-6223-e053-2995a90a7291	4
197979	metOLazone 2.5 MG Oral Tablet	PSN	0bc97c74-533a-40a6-bcaf-5374890c5846	2
311671	metOLazone 5 MG Oral Tablet	PSN	0bc97c74-533a-40a6-bcaf-5374890c5846	2
197979	metolazone 2.5 MG Oral Tablet	SCD	0bc97c74-533a-40a6-bcaf-5374890c5846	2
311671	metolazone 5 MG Oral Tablet	SCD	0bc97c74-533a-40a6-bcaf-5374890c5846	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69292-564-01	69292056401	100 TABLET in 1 BOTTLE (69292-564-01)	100 tablet	2021-05-15	0000-00-00	No	No	Current
69292-564-10	69292056410	1000 TABLET in 1 BOTTLE (69292-564-10)	1000 tablet	2021-05-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metolazone Tablets, USP Rx Only	Golden State Medical Supply, Inc.	2026-05-28	HUMAN PRESCRIPTION DRUG LABEL	5
Metolazone Tablets, USP Rx Only	Amici Pharma, Inc \| Amici Pharmaceuticals LLC. \| Innogenix, LLC	2026-04-01	HUMAN PRESCRIPTION DRUG LABEL	4
Metolazone Tablets, USP Rx Only	Major Pharmaceuticals	2025-07-22	HUMAN PRESCRIPTION DRUG LABEL	5
Metolazone Tablets, USP Rx Only	Bryant Ranch Prepack	2025-05-12	HUMAN PRESCRIPTION DRUG LABEL	102
Metolazone Tablets, USP Rx Only 8462401/0621F	American Health Packaging	2024-08-12	HUMAN PRESCRIPTION DRUG LABEL	2