Triamterene and Hydrochlorothiazide

Product NDC: 68084-750
11-digit product format: 680840750
Labeler code: 68084
Product ID: 68084-750_2b33a7d8-dfd0-3f8c-e063-6294a90abae3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Triamterene and Hydrochlorothiazide
Dosage form: TABLET
Route: ORAL
Labeler: American Health Packaging
Application: ANDA071251
Marketing category: ANDA
Marketing start: 2016-03-21
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 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…`

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
310812	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
ba764ce4-36fe-4aa4-96a4-d0479b875b4f	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
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	Strength	SPL version
68084-750-25	Triamterene and Hydrochlorothiazide	30 in 1 BOX, UNIT-DOSE	TABLET	30		7
68084-750-95	Triamterene and Hydrochlorothiazide	1 in 1 BLISTER PACK	TABLET	1		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-750-11	EA - Each	68084-750	28a718f4-3733-4a40-877d-89d7adec132e	1	2014-07-02
68084-750-21	EA - Each	68084-750	ffae8abb-b37c-487c-b293-9c4edad95264	1	2014-07-02
68084-750-25	EA - Each	68084-750	d09ec6d9-fc12-4124-89f0-425e61bd2fb2	1	2016-04-04
68084-750-95	EA - Each	68084-750	a65371df-88cd-455f-8254-0a22f1e6cc27	1	2016-04-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [AMERICAN HEALTH PACKAGING]	1
TRIAMTERENE	ACTIVE INGREDIENT	WS821Z52LQ	TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [AMERICAN HEALTH PACKAGING]	1
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [AMERICAN HEALTH PACKAGING]	1
TRIAMTERENE	ACTIVE MOIETY	WS821Z52LQ	TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [AMERICAN HEALTH PACKAGING]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [AMERICAN HEALTH PACKAGING]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [AMERICAN HEALTH PACKAGING]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [AMERICAN HEALTH PACKAGING]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [AMERICAN HEALTH PACKAGING]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [AMERICAN HEALTH PACKAGING]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [AMERICAN HEALTH PACKAGING]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68084-750	TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [AMERICAN HEALTH PACKAGING]	7	Current NDC, Legacy NDC, 2 package rows	20250110_ba764ce4-36fe-4aa4-96a4-d0479b875b4f.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 ndc (product): 68084-750
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
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
310812	triamterene 37.5 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	ba764ce4-36fe-4aa4-96a4-d0479b875b4f	7
310812	hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral Tablet	SCD	ba764ce4-36fe-4aa4-96a4-d0479b875b4f	7
310812	HCTZ 25 MG / triamterene 37.5 MG Oral Tablet	SY	ba764ce4-36fe-4aa4-96a4-d0479b875b4f	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68084-750-25	68084075025	30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-750-25) / 1 TABLET in 1 BLISTER PACK (68084-750-95)	30 blister pack	2016-03-21	0000-00-00	No	No	Current
68084-750-95	68084075095	1 in 1 BLISTER PACK						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Triamterene and Hydrochlorothiazide Tablets, USP Rx Only 8275021/0321F	American Health Packaging	2025-01-08	HUMAN PRESCRIPTION DRUG LABEL	7