Triamterene and Hydrochlorothiazide

Product NDC: 72578-090
11-digit product format: 725780090
Labeler code: 72578
Product ID: 72578-090_ba702c00-5dc6-4545-bde9-ff7dbb7fd1a7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Triamterene and Hydrochlorothiazide
Dosage form: CAPSULE
Route: ORAL
Labeler: Viona Pharmaceuticals Inc
Application: ANDA208358
Marketing category: ANDA
Marketing start: 2020-02-21
Substance: HYDROCHLOROTHIAZIDE; TRIAMTERENE
Active strength: 25; 37.5 mg/1; mg/1
Pharmacologic classes: Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]
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 42.

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
A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	25MG;37.5MG	CAPSULE / ORAL	AB		2019-02-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208358-001	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 · 42 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	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208358-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2019-02-11	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A208358-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208358-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208358-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208358-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208358-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208358-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208358-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208358-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208358-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208358-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208358-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208358-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208358-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208358-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208358-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208358-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208358-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208358-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208358-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208358-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208358-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208358-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208358-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208358-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208358-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208358-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208358-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208358-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208358-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208358-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208358-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208358-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208358-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208358-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208358-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208358-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208358-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208358-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208358-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208358-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Triamterene and Hydrochlorothiazide
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRIAMTERENE	25 mg/1
HYDROCHLOROTHIAZIDE	37.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WS821Z52LQ	Internal UNII lookup
0J48LPH2TH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198316	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
9925ab75-e3b7-43b7-888e-a2c8763240ba	Available on FDA.report

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
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72578-090-01	Triamterene and Hydrochlorothiazide	100 in 1 BOTTLE	CAPSULE	100	4
72578-090-05	Triamterene and Hydrochlorothiazide	500 in 1 BOTTLE	CAPSULE	500	4
72578-090-10	Triamterene and Hydrochlorothiazide	1000 in 1 BOTTLE	CAPSULE	1000	4
72578-090-30	Triamterene and Hydrochlorothiazide	10 in 1 BLISTER PACK	CAPSULE	10	4
72578-090-77	Triamterene and Hydrochlorothiazide	10 in 1 CARTON	CAPSULE	10	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72578-090-01	EA - Each	72578-090	1e6e8741-ed3d-462b-b8e0-f10d8a8b173c	1	2021-02-05
72578-090-10	EA - Each	72578-090	9462a17c-537f-43a8-b50a-09809b2cc44a	1	2021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72578-090	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [VIONA PHARMACEUTICALS INC]	4	Current NDC, Legacy NDC, 5 package rows	20231101_9925ab75-e3b7-43b7-888e-a2c8763240ba.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	Proficient Rx LP	4bc374e2-8650-41bc-8ce6-92062661bf8a	2026-07-01	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 208358 application number: ANDA208358
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	St. Mary's Medical Park Pharmacy	de5e7c85-5bf5-5b5f-e053-2995a90a1fba	2026-06-01	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 208358 application number: ANDA208358
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	08f3885e-dfde-79e4-e063-6394a90a4c09	2025-12-26	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 208358 application number: ANDA208358
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	7dc3414b-dcb5-4b11-bca7-c0fa3f474aea	2025-10-01	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 208358 application number: ANDA208358
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals Inc.	1fff8245-2b65-4ab1-aaa2-6bbbc6ac5fe8	2025-10-01	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 208358 application number: ANDA208358
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	8857b70b-861d-44f8-a671-78c06c83c029	2024-11-08	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 208358 application number: ANDA208358
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	d9fe1367-e725-4527-b515-95851d270b18	2024-11-08	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 208358 application number: ANDA208358
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals,Inc.	cba87d5b-9302-7b2c-e053-2a95a90a7f9d	2024-04-17	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 208358 application number: ANDA208358
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	5ca13106-f68b-4894-aca2-03e74fff350c	2024-04-03	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 208358 application number: ANDA208358
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Zydus Lifesciences Limited	e92f1118-8eaf-4fa8-b167-1447550af1ab	2023-10-31	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 208358 application number: ANDA208358
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Viona Pharmaceuticals Inc	9925ab75-e3b7-43b7-888e-a2c8763240ba	2023-10-31	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 208358 application number: ANDA208358 ndc (product): 72578-090
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Zydus Pharmaceuticals (USA) Inc.	ee11db7b-91bd-4231-8783-889d98e4fa32	2019-02-23	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 208358 application number: ANDA208358

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198316	hydroCHLOROthiazide 25 MG / triamterene 37.5 MG Oral Capsule	PSN	5ca13106-f68b-4894-aca2-03e74fff350c	102
198316	hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral Capsule	SCD	5ca13106-f68b-4894-aca2-03e74fff350c	102
198316	HCTZ 25 MG / triamterene 37.5 MG Oral Capsule	SY	5ca13106-f68b-4894-aca2-03e74fff350c	102
198316	hydroCHLOROthiazide 25 MG / triamterene 37.5 MG Oral Capsule	PSN	9925ab75-e3b7-43b7-888e-a2c8763240ba	4
198316	hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral Capsule	SCD	9925ab75-e3b7-43b7-888e-a2c8763240ba	4
198316	HCTZ 25 MG / triamterene 37.5 MG Oral Capsule	SY	9925ab75-e3b7-43b7-888e-a2c8763240ba	4
198316	hydroCHLOROthiazide 25 MG / triamterene 37.5 MG Oral Capsule	PSN	cba87d5b-9302-7b2c-e053-2a95a90a7f9d	3
198316	hydroCHLOROthiazide 25 MG / triamterene 37.5 MG Oral Capsule	PSN	08f3885e-dfde-79e4-e063-6394a90a4c09	3
198316	hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral Capsule	SCD	08f3885e-dfde-79e4-e063-6394a90a4c09	3
198316	hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral Capsule	SCD	cba87d5b-9302-7b2c-e053-2a95a90a7f9d	3
198316	HCTZ 25 MG / triamterene 37.5 MG Oral Capsule	SY	08f3885e-dfde-79e4-e063-6394a90a4c09	3
198316	HCTZ 25 MG / triamterene 37.5 MG Oral Capsule	SY	cba87d5b-9302-7b2c-e053-2a95a90a7f9d	3
198316	hydroCHLOROthiazide 25 MG / triamterene 37.5 MG Oral Capsule	PSN	7dc3414b-dcb5-4b11-bca7-c0fa3f474aea	2
198316	hydroCHLOROthiazide 25 MG / triamterene 37.5 MG Oral Capsule	PSN	1fff8245-2b65-4ab1-aaa2-6bbbc6ac5fe8	2
198316	hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral Capsule	SCD	7dc3414b-dcb5-4b11-bca7-c0fa3f474aea	2
198316	hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral Capsule	SCD	1fff8245-2b65-4ab1-aaa2-6bbbc6ac5fe8	2
198316	HCTZ 25 MG / triamterene 37.5 MG Oral Capsule	SY	7dc3414b-dcb5-4b11-bca7-c0fa3f474aea	2
198316	HCTZ 25 MG / triamterene 37.5 MG Oral Capsule	SY	1fff8245-2b65-4ab1-aaa2-6bbbc6ac5fe8	2
198316	hydroCHLOROthiazide 25 MG / triamterene 37.5 MG Oral Capsule	PSN	de5e7c85-5bf5-5b5f-e053-2995a90a1fba	1
198316	hydroCHLOROthiazide 25 MG / triamterene 37.5 MG Oral Capsule	PSN	d9fe1367-e725-4527-b515-95851d270b18	1
198316	hydroCHLOROthiazide 25 MG / triamterene 37.5 MG Oral Capsule	PSN	8857b70b-861d-44f8-a671-78c06c83c029	1
198316	hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral Capsule	SCD	8857b70b-861d-44f8-a671-78c06c83c029	1
198316	hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral Capsule	SCD	d9fe1367-e725-4527-b515-95851d270b18	1
198316	hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral Capsule	SCD	de5e7c85-5bf5-5b5f-e053-2995a90a1fba	1
198316	HCTZ 25 MG / triamterene 37.5 MG Oral Capsule	SY	d9fe1367-e725-4527-b515-95851d270b18	1
198316	HCTZ 25 MG / triamterene 37.5 MG Oral Capsule	SY	8857b70b-861d-44f8-a671-78c06c83c029	1
198316	HCTZ 25 MG / triamterene 37.5 MG Oral Capsule	SY	de5e7c85-5bf5-5b5f-e053-2995a90a1fba	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72578-090-01	72578009001	100 CAPSULE in 1 BOTTLE (72578-090-01)	100 capsule	2020-02-21	0000-00-00	No	No	Current
72578-090-05	72578009005	500 CAPSULE in 1 BOTTLE (72578-090-05)	500 capsule	2020-02-21	0000-00-00	No	No	Current
72578-090-10	72578009010	1000 CAPSULE in 1 BOTTLE (72578-090-10)	1000 capsule	2020-02-21	0000-00-00	No	No	Current
72578-090-30	72578009030	10 in 1 BLISTER PACK						Historical
72578-090-77	72578009077	10 BLISTER PACK in 1 CARTON (72578-090-77) / 10 CAPSULE in 1 BLISTER PACK (72578-090-30)	10 blister pack	2020-02-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Triamterene and Hydrochlorothiazide Capsules, USP Rx only	Proficient Rx LP	2026-07-01	HUMAN PRESCRIPTION DRUG LABEL	1
Triamterene and Hydrochlorothiazide Capsules, USP Rx only	St. Mary's Medical Park Pharmacy	2026-06-01	HUMAN PRESCRIPTION DRUG LABEL	5
Triamterene and Hydrochlorothiazide Capsules, USP Rx only	Northwind Health Company, LLC	2025-12-26	HUMAN PRESCRIPTION DRUG LABEL	3
Triamterene and Hydrochlorothiazide Capsules, USP Rx only	Preferred Pharmaceuticals Inc.	2025-10-01	HUMAN PRESCRIPTION DRUG LABEL	2
Triamterene and Hydrochlorothiazide Capsules, USP Rx only	REMEDYREPACK INC.	2025-10-01	HUMAN PRESCRIPTION DRUG LABEL	2
Triamterene and Hydrochlorothiazide Capsules, USP Rx only	A-S Medication Solutions	2024-11-08	HUMAN PRESCRIPTION DRUG LABEL	1
Triamterene and Hydrochlorothiazide Capsules, USP Rx only	A-S Medication Solutions	2024-11-08	HUMAN PRESCRIPTION DRUG LABEL	1
Triamterene and Hydrochlorothiazide Capsules, USP Rx only	NuCare Pharmaceuticals,Inc.	2024-04-17	HUMAN PRESCRIPTION DRUG LABEL	3
Triamterene and Hydrochlorothiazide Capsules, USP Rx only	Bryant Ranch Prepack	2024-04-03	HUMAN PRESCRIPTION DRUG LABEL	102
Triamterene and Hydrochlorothiazide Capsules, USP Rx only	Viona Pharmaceuticals Inc \| Zydus Pharmaceuticals (USA) Inc. \| Zydus Lifesciences Limited	2023-10-31	HUMAN PRESCRIPTION DRUG LABEL	4
Triamterene and Hydrochlorothiazide Capsules, USP Rx only	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-01	HUMAN PRESCRIPTION DRUG LABEL	1