Metolazone

Product NDC: 71610-285
Requested package NDC: 71610-285-09
11-digit product format: 716100285
Labeler code: 71610
Product ID: 71610-285_875c85ff-ca13-41b1-bc4e-ca871c3d2cd1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metolazone
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA076732
Marketing category: ANDA
Marketing start: 2003-12-19
Substance: METOLAZONE
Active strength: 2.5 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

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076732-001	METOLAZONE	METOLAZONE	2.5MG	TABLET / ORAL	AB		2003-12-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076732-001	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 2 · 41 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	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A076732-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076732-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076732-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076732-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076732-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076732-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076732-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076732-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076732-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076732-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076732-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076732-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076732-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076732-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076732-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076732-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076732-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076732-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076732-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076732-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076732-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076732-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076732-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076732-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076732-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076732-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076732-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076732-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076732-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076732-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076732-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076732-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076732-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076732-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076732-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076732-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076732-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076732-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076732-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076732-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Metolazone
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METOLAZONE	2.5 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
71f86ee1-9e43-482b-9ad8-ec5d5576f360	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
71610-285-09	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
71610-285-09	EA - Each	71610-285	932eae92-60d2-4768-b6f2-58b52c7c5d22	1	2019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-285	METOLAZONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Current NDC, 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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metolazone	METOLAZONE	Bryant Ranch Prepack	34f91465-7a97-e543-e063-6294a90a1ac7	2025-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076732 application number: ANDA076732
Metolazone	METOLAZONE	Sandoz Inc	0b619826-2567-49d7-8972-b6da5e4467df	2025-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076732 application number: ANDA076732
Metolazone	METOLAZONE	Bryant Ranch Prepack	88c93278-7cf6-4f84-bc03-44bfb8b91e37	2023-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076732 application number: ANDA076732
Metolazone	METOLAZONE	Aphena Pharma Solutions - Tennessee, LLC	71f86ee1-9e43-482b-9ad8-ec5d5576f360	2019-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076732 application number: ANDA076732 ndc (package): 71610-285-09 ndc (product): 71610-285 ndc11 (package): 71610028509

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
71610-285-09	71610028509	9000 TABLET in 1 BOTTLE (71610-285-09)	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