Triamterene and Hydrochlorothiazide

Product NDC: 0527-1632
Requested package NDC: 0527-1632-01
11-digit product format: 005271632
Labeler code: 0527
Product ID: 0527-1632_4d422902-e50b-4596-a753-5d5a9b29b209
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Triamterene and Hydrochlorothiazide
Dosage form: CAPSULE
Route: ORAL
Labeler: Lannett Company, Inc.
Application: ANDA201407
Marketing category: ANDA
Marketing start: 2011-12-09
Marketing end: 0000-00-00
Substance: HYDROCHLOROTHIAZIDE; TRIAMTERENE
Active strength: 25 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: 2023-12-31
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	0527-1632	0527-1632-01	I	Inactivated by FDA		2026-08-10

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 · 11 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	25MG;37.5MG	CAPSULE / ORAL	AB		2011-12-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201407-001	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 · 41 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	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201407-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	2011-12-09	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A201407-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201407-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201407-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201407-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201407-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201407-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201407-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201407-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201407-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201407-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201407-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201407-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201407-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201407-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201407-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201407-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201407-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201407-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201407-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201407-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201407-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201407-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201407-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201407-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201407-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201407-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201407-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201407-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201407-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201407-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201407-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201407-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201407-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201407-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201407-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201407-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201407-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201407-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201407-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201407-001	AB	1	`cb3db0bc1861…`

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
162cbc9d-ecc3-72ba-af9f-c76e2756ef54	Product name	3	20221207
9b303cd4-3186-2454-5706-3137e8b2dfd2	Product name	4	20221110
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
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
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
00fc2cf9-672f-3e0b-6afa-43cbc864d058	Product name	4	20180613
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
0527-1632-01	2024-07-30	Triamterene and Hydrochlorothiazide Capsules, USP Rx Only
0527-1632-10	2024-07-30	Triamterene and Hydrochlorothiazide Capsules, USP Rx Only
0527-1632-01	2024-01-30	Triamterene and Hydrochlorothiazide Capsules, USP Rx Only
0527-1632-10	2024-01-30	Triamterene and Hydrochlorothiazide Capsules, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0527-1632-01	Triamterene and Hydrochlorothiazide	100 in 1 BOTTLE	CAPSULE	100		15
0527-1632-10	Triamterene and Hydrochlorothiazide	1000 in 1 BOTTLE	CAPSULE	1000		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0527-1632-01	EA - Each	0527-1632	69c21794-c0de-4b14-93b6-0a2efd08d328	1	2012-07-24
0527-1632-10	EA - Each	0527-1632	1abe6457-9481-4140-b135-0f6e7b89edf3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [LANNETT COMPANY, INC.]	8
TRIAMTERENE	ACTIVE INGREDIENT	WS821Z52LQ	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [LANNETT COMPANY, INC.]	8
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [LANNETT COMPANY, INC.]	8
TRIAMTERENE	ACTIVE MOIETY	WS821Z52LQ	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [LANNETT COMPANY, INC.]	8
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [LANNETT COMPANY, INC.]	8
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [LANNETT COMPANY, INC.]	8
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [LANNETT COMPANY, INC.]	8
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [LANNETT COMPANY, INC.]	8
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [LANNETT COMPANY, INC.]	8
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [LANNETT COMPANY, INC.]	8
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [LANNETT COMPANY, INC.]	8
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [LANNETT COMPANY, INC.]	8
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [LANNETT COMPANY, INC.]	8
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [LANNETT COMPANY, INC.]	8
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [LANNETT COMPANY, INC.]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [LANNETT COMPANY, INC.]	8
METHYL ALCOHOL	INACTIVE INGREDIENT	Y4S76JWI15	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [LANNETT COMPANY, INC.]	8
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [LANNETT COMPANY, INC.]	8
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [LANNETT COMPANY, INC.]	8
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [LANNETT COMPANY, INC.]	8
SHELLAC	INACTIVE INGREDIENT	46N107B71O	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [LANNETT COMPANY, INC.]	8
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [LANNETT COMPANY, INC.]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [LANNETT COMPANY, INC.]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [LANNETT COMPANY, INC.]	8
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	TRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) CAPSULE [AVKARE, INC.]	1
TRIAMTERENE	ACTIVE INGREDIENT	WS821Z52LQ	TRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) CAPSULE [AVKARE, INC.]	1
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	TRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) CAPSULE [AVKARE, INC.]	1
TRIAMTERENE	ACTIVE MOIETY	WS821Z52LQ	TRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) CAPSULE [AVKARE, INC.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	TRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) CAPSULE [AVKARE, INC.]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	TRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) CAPSULE [AVKARE, INC.]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	TRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) CAPSULE [AVKARE, INC.]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	TRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) CAPSULE [AVKARE, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	TRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) CAPSULE [AVKARE, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) CAPSULE [AVKARE, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	TRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) CAPSULE [AVKARE, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) CAPSULE [AVKARE, INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) CAPSULE [AVKARE, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) CAPSULE [AVKARE, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) CAPSULE [AVKARE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) CAPSULE [AVKARE, INC.]	1
METHYL ALCOHOL	INACTIVE INGREDIENT	Y4S76JWI15	TRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) CAPSULE [AVKARE, INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	TRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) CAPSULE [AVKARE, INC.]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	TRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) CAPSULE [AVKARE, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) CAPSULE [AVKARE, INC.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	TRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) CAPSULE [AVKARE, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) CAPSULE [AVKARE, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) CAPSULE [AVKARE, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRIAMTERENE AND HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) CAPSULE [AVKARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0527-1632	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [LANNETT COMPANY, INC.]	15	Legacy NDC, 2 package rows	20220729_b23d4978-0d47-457a-8176-0e8c567d5dd1.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRIAMTERENE AND HYDROCHLOROTHIAZIDE	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Chartwell RX, LLC	261dd83f-8048-488f-8b71-c4abd9692720	2025-12-10	Adverse reactions	Exact identifier application applno (ANDA): 201407 application number: ANDA201407
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	d692b189-1b06-46f5-a257-758a7dede863	2024-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201407 application number: ANDA201407
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	6517777a-e49e-4da6-b34b-66ec58cceff7	2024-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201407 application number: ANDA201407
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	8cc154c2-2ed2-4d7c-95a5-e2946393270c	2023-05-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201407 application number: ANDA201407
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Proficient Rx LP	189ad040-07e9-42a5-854c-67633367da74	2023-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201407 application number: ANDA201407

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	8cc154c2-2ed2-4d7c-95a5-e2946393270c	100
198316	hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral Capsule	SCD	8cc154c2-2ed2-4d7c-95a5-e2946393270c	100
198316	HCTZ 25 MG / triamterene 37.5 MG Oral Capsule	SY	8cc154c2-2ed2-4d7c-95a5-e2946393270c	100
198316	hydroCHLOROthiazide 25 MG / triamterene 37.5 MG Oral Capsule	PSN	d692b189-1b06-46f5-a257-758a7dede863	16
198316	hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral Capsule	SCD	d692b189-1b06-46f5-a257-758a7dede863	16
198316	HCTZ 25 MG / triamterene 37.5 MG Oral Capsule	SY	d692b189-1b06-46f5-a257-758a7dede863	16
198316	hydroCHLOROthiazide 25 MG / triamterene 37.5 MG Oral Capsule	PSN	b23d4978-0d47-457a-8176-0e8c567d5dd1	15
198316	hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral Capsule	SCD	b23d4978-0d47-457a-8176-0e8c567d5dd1	15
198316	HCTZ 25 MG / triamterene 37.5 MG Oral Capsule	SY	b23d4978-0d47-457a-8176-0e8c567d5dd1	15
198316	hydroCHLOROthiazide 25 MG / triamterene 37.5 MG Oral Capsule	PSN	189ad040-07e9-42a5-854c-67633367da74	5
198316	hydroCHLOROthiazide 25 MG / triamterene 37.5 MG Oral Capsule	PSN	e71c754d-78bd-42f5-8691-5c4118ca859f	5
198316	hydroCHLOROthiazide 25 MG / triamterene 37.5 MG Oral Capsule	PSN	6517777a-e49e-4da6-b34b-66ec58cceff7	5
198316	hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral Capsule	SCD	6517777a-e49e-4da6-b34b-66ec58cceff7	5
198316	hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral Capsule	SCD	189ad040-07e9-42a5-854c-67633367da74	5
198316	hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral Capsule	SCD	e71c754d-78bd-42f5-8691-5c4118ca859f	5
198316	HCTZ 25 MG / triamterene 37.5 MG Oral Capsule	SY	6517777a-e49e-4da6-b34b-66ec58cceff7	5
198316	HCTZ 25 MG / triamterene 37.5 MG Oral Capsule	SY	189ad040-07e9-42a5-854c-67633367da74	5
198316	HCTZ 25 MG / triamterene 37.5 MG Oral Capsule	SY	e71c754d-78bd-42f5-8691-5c4118ca859f	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0527-1632-01	00527163201	100 CAPSULE in 1 BOTTLE (0527-1632-01)	100 capsule	2011-12-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Triamterene and Hydrochlorothiazide Capsules, USP Rx Only	NuCare Pharmaceuticals, Inc.	2024-07-19	HUMAN PRESCRIPTION DRUG LABEL	5
Triamterene and Hydrochlorothiazide Capsules, USP Rx Only	REMEDYREPACK INC.	2024-04-04	HUMAN PRESCRIPTION DRUG LABEL	2
Triamterene and Hydrochlorothiazide Capsules, USP Rx Only	A-S Medication Solutions	2024-01-31	HUMAN PRESCRIPTION DRUG LABEL	16
Triamterene and Hydrochlorothiazide Capsules, USP Rx Only	Bryant Ranch Prepack	2024-01-16	HUMAN PRESCRIPTION DRUG LABEL	5
Triamterene and Hydrochlorothiazide Capsules, USP Rx Only	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5
Triamterene and Hydrochlorothiazide Capsules, USP Rx Only	Bryant Ranch Prepack	2023-05-09	HUMAN PRESCRIPTION DRUG LABEL	100
Triamterene and Hydrochlorothiazide Capsules, USP Rx Only	Proficient Rx LP	2023-01-01	HUMAN PRESCRIPTION DRUG LABEL	5
Triamterene and Hydrochlorothiazide Capsules, USP Rx Only	Northwind Pharmaceuticals	2023-01-01	HUMAN PRESCRIPTION DRUG LABEL	1
Triamterene and Hydrochlorothiazide Capsules, USP Rx Only	AvKARE	2022-01-17	HUMAN PRESCRIPTION DRUG LABEL	5
Triamterene and Hydrochlorothiazide Capsules, USP Rx Only	Lannett Company, Inc. \| Legacy Pharmaceutical Packaging, LLC	2020-09-11	HUMAN PRESCRIPTION DRUG LABEL	15
Triamterene and Hydrochlorothiazide Capsules, USP Rx Only	Lake Erie Medical DBA Quality Care Products LLC	2020-03-13	HUMAN PRESCRIPTION DRUG LABEL	3
Triamterene and Hydrochlorothiazide Capsules, USP Rx Only	NuCare Pharmaceuticals, Inc.	2020-01-22	HUMAN PRESCRIPTION DRUG LABEL	2
Triamterene and Hydrochlorothiazide Capsules, USP Rx Only	St. Mary's Medical Park Pharmacy	2020-01-22	HUMAN PRESCRIPTION DRUG LABEL	2
Triamterene and Hydrochlorothiazide Capsules, USP Rx Only	Preferred Pharmaceuticals Inc.	2019-04-15	HUMAN PRESCRIPTION DRUG LABEL	3