Metolazone

Product NDC: 0185-5600
11-digit product format: 001855600
Labeler code: 0185
Product ID: 0185-5600_5d900b8f-93d6-46d0-8db9-7fe9e3791a2f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metolazone
Dosage form: TABLET
Route: ORAL
Labeler: Sandoz Inc
Application: ANDA076466
Marketing category: ANDA
Marketing start: 2003-12-19
Substance: METOLAZONE
Active strength: 10 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 · 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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METOLAZONE	10 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
0b619826-2567-49d7-8972-b6da5e4467df	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
0185-5600-01	Metolazone	100 in 1 BOTTLE	TABLET	100		20
0185-5600-10	Metolazone	1000 in 1 BOTTLE	TABLET	1000		20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0185-5600-01	EA - Each	0185-5600	823451f6-e273-4abd-96f0-01e87395de9e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METOLAZONE	ACTIVE INGREDIENT	TZ7V40X7VX	METOLAZONE TABLET [EON LABS, INC.]	16
METOLAZONE	ACTIVE MOIETY	TZ7V40X7VX	METOLAZONE TABLET [EON LABS, INC.]	16
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METOLAZONE TABLET [EON LABS, INC.]	16
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	METOLAZONE TABLET [EON LABS, INC.]	16
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	METOLAZONE TABLET [EON LABS, INC.]	16
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	METOLAZONE TABLET [EON LABS, INC.]	16
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	METOLAZONE TABLET [EON LABS, INC.]	16
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METOLAZONE TABLET [EON LABS, INC.]	16
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METOLAZONE TABLET [EON LABS, INC.]	16
METOLAZONE	ACTIVE INGREDIENT	TZ7V40X7VX	METOLAZONE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
METOLAZONE	ACTIVE MOIETY	TZ7V40X7VX	METOLAZONE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METOLAZONE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	METOLAZONE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	METOLAZONE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	METOLAZONE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	METOLAZONE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METOLAZONE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METOLAZONE TABLET [PHYSICIANS TOTAL CARE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0185-5600	METOLAZONE TABLET [SANDOZ INC]	19	Current NDC, Legacy NDC, 2 package rows	20240316_0b619826-2567-49d7-8972-b6da5e4467df.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 · 5 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 ndc (product): 0185-5600
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

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
197978	metOLazone 10 MG Oral Tablet	PSN	0b619826-2567-49d7-8972-b6da5e4467df	20
197979	metOLazone 2.5 MG Oral Tablet	PSN	0b619826-2567-49d7-8972-b6da5e4467df	20
311671	metOLazone 5 MG Oral Tablet	PSN	0b619826-2567-49d7-8972-b6da5e4467df	20
197978	metolazone 10 MG Oral Tablet	SCD	0b619826-2567-49d7-8972-b6da5e4467df	20
197979	metolazone 2.5 MG Oral Tablet	SCD	0b619826-2567-49d7-8972-b6da5e4467df	20
311671	metolazone 5 MG Oral Tablet	SCD	0b619826-2567-49d7-8972-b6da5e4467df	20
197978	metOLazone 10 MG Oral Tablet	PSN	78105e5c-5d36-426c-9f79-f2e085460b75	2
197979	metOLazone 2.5 MG Oral Tablet	PSN	78105e5c-5d36-426c-9f79-f2e085460b75	2
311671	metOLazone 5 MG Oral Tablet	PSN	78105e5c-5d36-426c-9f79-f2e085460b75	2
197978	metolazone 10 MG Oral Tablet	SCD	78105e5c-5d36-426c-9f79-f2e085460b75	2
197979	metolazone 2.5 MG Oral Tablet	SCD	78105e5c-5d36-426c-9f79-f2e085460b75	2
311671	metolazone 5 MG Oral Tablet	SCD	78105e5c-5d36-426c-9f79-f2e085460b75	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0185-5600-01	00185560001	100 TABLET in 1 BOTTLE (0185-5600-01)	100 tablet	2003-12-19	0000-00-00	No	No	Current
0185-5600-10	00185560010	1000 TABLET in 1 BOTTLE (0185-5600-10)	1000 tablet	2003-12-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
METOLAZONE TABLETS, USP	Sandoz Inc	2025-03-19	HUMAN PRESCRIPTION DRUG LABEL	20
Metolazone Tablets USP	Physicians Total Care, Inc.	2012-04-24	HUMAN PRESCRIPTION DRUG LABEL	2