Triamterene and Hydrochlorothiazide

Product NDC: 50090-0372
11-digit product format: 500900372
Labeler code: 50090
Product ID: 50090-0372_989411c9-0dc5-4c3a-851f-80e7a50d522b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Triamterene and Hydrochlorothiazide
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA071251
Marketing category: ANDA
Marketing start: 2009-09-21
Marketing end: 0000-00-00
Substance: TRIAMTERENE; HYDROCHLOROTHIAZIDE
Active strength: 75 mg/1; mg/1
Pharmacologic classes: Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50090-0372		D	Discontinued by firm	2026-08-11
excluded package	package	50090-0372	50090-0372-0	D	Discontinued by firm	2026-08-11
excluded package	package	50090-0372	50090-0372-2	D	Discontinued by firm	2026-08-11
excluded package	package	50090-0372	50090-0372-5	D	Discontinued by firm	2026-08-11

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-0372-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-0372-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-0372-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-0372-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-0372-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-0372-2	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A071251-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	50MG;75MG	TABLET / ORAL	AB		1988-04-17
A071251-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	25MG;37.5MG	TABLET / ORAL	AB		1998-05-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071251-001	AB
A071251-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A071251-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	1988-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071251-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	1998-05-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071251-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	1988-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071251-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	1998-05-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071251-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	1988-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071251-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	1998-05-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071251-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	1988-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071251-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	1998-05-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071251-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	1988-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071251-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	1998-05-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071251-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	1988-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071251-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	1998-05-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071251-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	1988-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071251-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	1998-05-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071251-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	1988-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071251-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	1998-05-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071251-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	1988-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071251-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	1998-05-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071251-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	1988-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071251-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	1998-05-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071251-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	1988-04-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071251-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	1998-05-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071251-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	1988-04-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071251-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	1998-05-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071251-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	1988-04-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071251-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	1998-05-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071251-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	1988-04-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A071251-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	1998-05-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071251-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	1988-04-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071251-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	1998-05-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071251-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	1988-04-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A071251-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	1998-05-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071251-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	1988-04-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A071251-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	1998-05-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071251-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	1988-04-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071251-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	1998-05-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071251-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	1988-04-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A071251-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	1998-05-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071251-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	50MG;75MG	TABLET / ORAL	AB	1988-04-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A071251-002	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	TABLET / ORAL	AB	1998-05-05	`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	A071251-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071251-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071251-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071251-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071251-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071251-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071251-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071251-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071251-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071251-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071251-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071251-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071251-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071251-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071251-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071251-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071251-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071251-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071251-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071251-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071251-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071251-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071251-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071251-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071251-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071251-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071251-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A071251-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071251-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071251-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071251-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A071251-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071251-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A071251-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071251-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071251-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071251-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A071251-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071251-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A071251-002	AB	1	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-0372-0	2023-02-07	Triamterene and Hydrochlorothiazide Tablets, 37.5 mg/ 25 mg and 75 mg/50 mg
50090-0372-2	2023-02-07	Triamterene and Hydrochlorothiazide Tablets, 37.5 mg/ 25 mg and 75 mg/50 mg
50090-0372-5	2023-02-07	Triamterene and Hydrochlorothiazide Tablets, 37.5 mg/ 25 mg and 75 mg/50 mg
50090-0372-0	2023-01-30	Triamterene and Hydrochlorothiazide Tablets, 37.5 mg/ 25 mg and 75 mg/50 mg
50090-0372-2	2023-01-30	Triamterene and Hydrochlorothiazide Tablets, 37.5 mg/ 25 mg and 75 mg/50 mg
50090-0372-5	2023-01-30	Triamterene and Hydrochlorothiazide Tablets, 37.5 mg/ 25 mg and 75 mg/50 mg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-0372-0	EA - Each	50090-0372	2d109c7c-13b8-4a33-b040-064c71e50706	1	2018-09-05
50090-0372-2	EA - Each	50090-0372	8b8aff84-55c3-4fa3-8777-c2ab7944a36e	1	2018-09-05
50090-0372-5	EA - Each	50090-0372	e1a47f01-da6b-42e8-80be-c5fe7ea5d4c6	1	2018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-0372	TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [A-S MEDICATION SOLUTIONS]	18	Legacy NDC	20230208_64f85f9c-80eb-45db-8527-063fc12f8345.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	PD-Rx Pharmaceuticals, Inc.	f083c321-3170-4982-b5cd-d3fdff754857	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071251 application number: ANDA071251
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Apotex Corp.	bd6c3495-ec70-908b-482a-a979506659e9	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071251 application number: ANDA071251
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Golden State Medical Supply, Inc.	9fe534cd-cf5f-64b4-e053-2995a90a926e	2026-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071251 application number: ANDA071251
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	f32b8809-80e9-18f2-e053-2995a90a5428	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071251 application number: ANDA071251
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	9ec3d35f-b25d-48f4-926f-f093e402ccde	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071251 application number: ANDA071251
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	BluePoint Laboratories	4f44fb73-7f61-4623-ae89-61abd8e945ab	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071251 application number: ANDA071251
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	5ba2c08b-5ce5-4967-bc3b-2c73df9865af	2025-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071251 application number: ANDA071251
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	ec6dce85-5c0b-475c-af0b-cbbc034f698f	2025-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071251 application number: ANDA071251
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	American Health Packaging	ba764ce4-36fe-4aa4-96a4-d0479b875b4f	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071251 application number: ANDA071251
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Aphena Pharma Solutions - Tennessee, LLC	15e6f934-fe66-4640-bdf1-13b389cd9e54	2023-01-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071251 application number: ANDA071251
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Aphena Pharma Solutions - Tennessee, LLC	b129e54a-a6d8-42c0-baac-e8db2487369b	2021-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071251 application number: ANDA071251
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Aphena Pharma Solutions - Tennessee, LLC	191b9e48-7d44-4378-9f3f-b4a999080c8c	2020-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071251 application number: ANDA071251

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WS821Z52LQ	TRIAMTERENE	396-01-0	TRIAMTERENE
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-0372-0	50090037200	30 TABLET in 1 BOTTLE (50090-0372-0)	30 tablet	2016-06-29	0000-00-00	No	No	Current
50090-0372-2	50090037202	100 TABLET in 1 BOTTLE (50090-0372-2)	100 tablet	2016-06-29	0000-00-00	No	No	Current
50090-0372-5	50090037205	90 TABLET in 1 BOTTLE (50090-0372-5)	90 tablet	2016-06-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Triamterene and Hydrochlorothiazide Tablets, 37.5 mg/ 25 mg and 75 mg/50 mg	A-S Medication Solutions	2023-02-04	HUMAN PRESCRIPTION DRUG LABEL	18