Triamterene and Hydrochlorothiazide

Product NDC: 53002-2252
Requested package NDC: 53002-2252-3
11-digit product format: 530022252
Labeler code: 53002
Product ID: 53002-2252_efc365bd-d5d0-4589-a46b-02508a93fed8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Triamterene and Hydrochlorothiazide
Dosage form: TABLET
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA071251
Marketing category: ANDA
Marketing start: 2009-09-21
Marketing end: 0000-00-00
Substance: TRIAMTERENE; HYDROCHLOROTHIAZIDE
Active strength: 38 mg/1; mg/1
Pharmacologic classes: Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS],Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC]
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53002-2252	53002-2252-3	I	Inactivated by FDA		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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1	Product name	3	20260303
1199f4b7-b537-466c-9a1c-cb09131e9f8b	Product name	1	20251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6f	Product name	3	20251027
b15e9aa6-d523-ca97-480e-570e0543a342	Product name	4	20251024
96816964-c075-ffa7-b7b8-d8570411a3b9	Product name	7	20250305
162cbc9d-ecc3-72ba-af9f-c76e2756ef54	Product name	3	20221207
9b303cd4-3186-2454-5706-3137e8b2dfd2	Product name	4	20221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0ea	Product name	1	20200505
b2ea36e8-564d-01b9-8552-a327d058eb0f	Product name	2	20200203
a8e65197-7914-7acf-c7ec-914d53819b34	Product name	3	20190624
8b67f333-47d1-8464-7ce4-406d3dbb295f	Product name	7	20190618
89a57420-ab44-5323-14f9-595159145f9b	Product name	2	20190612
c27b049d-3258-48cf-ebe5-08c236ae78e2	Product name	3	20190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058	Product name	4	20180613
15b375b1-89c7-9594-80df-5a8c8864aee0	Product name	3	20180108
a7349398-661d-d9fc-46df-7e128bbd61d9	Product name	5	20171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3d	Product name	2	20170719
e0eeb018-194e-4b70-a57d-bac47a97b8ea	Product name	1	20160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502	Product name	2	20150320
ea069444-e874-4c28-833f-d2f52734ef4d	Product name	1	20150206
041df61b-f8b6-48a6-7b67-411e1412678b	Product name	1	20140508
0ad8bdca-888e-00da-648b-6a4de854a167	Product name	1	20140508
433a3439-b8f3-d13a-d2c8-9b221d628d60	Product name	1	20140508
59212689-39e5-a976-6d21-882d76d8079a	Product name	1	20140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212	Product name	1	20140508
78637fb0-95c8-441f-e4b4-db1274b6f956	Product name	1	20140508
df89bd47-2db4-d593-ab37-d11953fd5536	Product name	1	20140508
f151007d-265d-9fbe-857d-1d44f1cb76ba	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
53002-2252-0	2025-01-30	Triamterene and Hydrochlorothiazide Tablets, 37.5 mg/ 25 mg and 75 mg/50 mg
53002-2252-3	2025-01-30	Triamterene and Hydrochlorothiazide Tablets, 37.5 mg/ 25 mg and 75 mg/50 mg
53002-2252-0	2023-06-07	Triamterene and Hydrochlorothiazide Tablets, 37.5 mg/ 25 mg and 75 mg/50 mg
53002-2252-3	2023-06-07	Triamterene and Hydrochlorothiazide Tablets, 37.5 mg/ 25 mg and 75 mg/50 mg
53002-2252-0	2023-01-30	Triamterene and Hydrochlorothiazide Tablets, 37.5 mg/ 25 mg and 75 mg/50 mg
53002-2252-3	2023-01-30	Triamterene and Hydrochlorothiazide Tablets, 37.5 mg/ 25 mg and 75 mg/50 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53002-2252-0	Triamterene and Hydrochlorothiazide	100 in 1 BOTTLE	TABLET	100		4
53002-2252-3	Triamterene and Hydrochlorothiazide	30 in 1 BOTTLE	TABLET	30		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-2252	TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [RPK PHARMACEUTICALS, INC.]	4	Legacy NDC, 2 package rows	20230609_90277796-e95a-4e0e-b1d4-784b920cc7bb.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310812	triamterene 37.5 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	90277796-e95a-4e0e-b1d4-784b920cc7bb	4
310812	hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral Tablet	SCD	90277796-e95a-4e0e-b1d4-784b920cc7bb	4
310812	HCTZ 25 MG / triamterene 37.5 MG Oral Tablet	SY	90277796-e95a-4e0e-b1d4-784b920cc7bb	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-2252-3	53002225203	30 TABLET in 1 BOTTLE (53002-2252-3)	30 tablet	2021-05-01	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	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	4