Application 216211

Type: ANDA
Sponsor: RUBICON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	TABLET;ORAL	25MG;37.5MG	No	No
002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	TABLET;ORAL	50MG;75MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A216211-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	25MG;37.5MG	TABLET / ORAL	AB		2022-02-23
A216211-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	50MG;75MG	TABLET / ORAL	AB		2022-02-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216211-001	AB
A216211-002	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 2 · 64 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
2026-08-18 06:07:40	2026-07	A216211-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2022-02-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216211-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2022-02-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216211-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2022-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216211-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2022-02-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216211-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2022-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216211-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2022-02-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216211-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2022-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216211-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2022-02-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216211-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2022-02-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216211-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2022-02-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216211-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2022-02-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216211-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2022-02-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216211-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2022-02-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216211-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2022-02-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216211-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2022-02-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216211-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2022-02-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216211-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2022-02-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216211-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2022-02-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216211-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2022-02-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216211-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2022-02-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216211-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2022-02-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216211-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2022-02-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216211-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2022-02-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216211-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2022-02-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216211-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2022-02-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216211-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2022-02-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216211-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2022-02-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216211-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2022-02-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216211-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2022-02-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216211-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2022-02-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216211-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2022-02-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216211-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2022-02-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A216211-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2022-02-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A216211-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2022-02-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A216211-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2022-02-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A216211-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2022-02-23	`4b0b4de00fa7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216211-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2022-02-23	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216211-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2022-02-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216211-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	2022-02-23	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216211-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	2022-02-23	`1c564ffb4f44…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 64 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A216211-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216211-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216211-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216211-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216211-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216211-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216211-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216211-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216211-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216211-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216211-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216211-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216211-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216211-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216211-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216211-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216211-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216211-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216211-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216211-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216211-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216211-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216211-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216211-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216211-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216211-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216211-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216211-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216211-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216211-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216211-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216211-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A216211-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A216211-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A216211-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A216211-002	AB	1	`4b0b4de00fa7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216211-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216211-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216211-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216211-002	AB	1	`1c564ffb4f44…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	0de72197-607f-ef0a-e063-6394a90a8949	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216211 application number: ANDA216211
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	03b11335-2e88-2f7b-e063-6394a90afe2a	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216211 application number: ANDA216211
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	f3bc491a-961d-4a38-8a55-c4a03be05b74	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216211 application number: ANDA216211
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	e7c34985-a8be-45d3-9273-2b13e2f6b7b2	2026-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216211 application number: ANDA216211
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Advagen Pharma Ltd	a5525a2a-d2c7-411b-9ffc-0cc4fe77f7c7	2026-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216211 application number: ANDA216211 ndc (product): 72888-095 ndc (product): 72888-094
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	02752dae-30b7-4726-b22b-985b330a2060	2025-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216211 application number: ANDA216211
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals Inc.	5fc69fbf-c2d2-41ef-99bb-62a76ef74db2	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216211 application number: ANDA216211
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	5ee165a3-39a4-4d12-aff2-a6fb3309ce39	2025-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216211 application number: ANDA216211

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72888-094	Triamterene and Hydrochlorothiazide	Triamterene and Hydrochlorothiazide	Advagen Pharma Ltd	ANDA	Current
72888-095	Triamterene and Hydrochlorothiazide	Triamterene and Hydrochlorothiazide	Advagen Pharma Ltd	ANDA	Current