Tekturna HCT

Product NDC: 70839-112
11-digit product format: 708390112
Labeler code: 70839
Product ID: 70839-112_ed9274e4-086a-0713-e053-2a95a90ae88d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: aliskiren hemifumarate and hydrochlorothiazide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Noden Pharma USA, Inc.
Application: NDA022107
Marketing category: NDA
Marketing start: 2008-08-01
Marketing end: 0000-00-00
Substance: ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE
Active strength: 150 mg/1; mg/1
Pharmacologic classes: Increased Diuresis [PE], Renin Inhibitor [EPC], Renin Inhibitors [MoA], 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70839-112		I	Inactivated by FDA	2026-08-17
excluded package	package	70839-112	70839-112-01	D	Discontinued by firm	2026-08-17
excluded package	package	70839-112	70839-112-30	D	Discontinued by firm	2026-08-17
excluded package	package	70839-112	70839-112-90	D	Discontinued by firm	2026-08-17

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 · 51 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70839-112-90	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70839-112-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70839-112-30	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70839-112-90	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70839-112-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70839-112-30	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70839-112-90	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70839-112-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70839-112-30	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70839-112-90	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70839-112-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70839-112-30	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70839-112-90	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70839-112-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70839-112-30	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70839-112-90	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70839-112-01	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70839-112-30	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70839-112-90	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70839-112-01	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70839-112-30	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70839-112-90	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70839-112-01	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70839-112-30	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70839-112-90	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70839-112-01	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70839-112-30	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70839-112-90	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70839-112-01	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70839-112-30	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70839-112-90	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70839-112-01	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70839-112-30	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70839-112-90	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70839-112-01	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70839-112-30	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N022107-001	TEKTURNA HCT	ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE	EQ 150MG BASE;12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18
N022107-002	TEKTURNA HCT	ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE	EQ 150MG BASE;25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18
N022107-003	TEKTURNA HCT	ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE	EQ 300MG BASE;12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18
N022107-004	TEKTURNA HCT	ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE	EQ 300MG BASE;25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status
N022107-001	8618172	2028-07-13	Drug product
N022107-002	8618172	2028-07-13	Drug product
N022107-003	8618172	2028-07-13	Drug product
N022107-004	8618172	2028-07-13	Drug product

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 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022107-001	TEKTURNA HCT	EQ 150MG BASE;12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022107-002	TEKTURNA HCT	EQ 150MG BASE;25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022107-003	TEKTURNA HCT	EQ 300MG BASE;12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022107-004	TEKTURNA HCT	EQ 300MG BASE;25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022107-001	TEKTURNA HCT	EQ 150MG BASE;12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022107-002	TEKTURNA HCT	EQ 150MG BASE;25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022107-003	TEKTURNA HCT	EQ 300MG BASE;12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022107-004	TEKTURNA HCT	EQ 300MG BASE;25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022107-001	TEKTURNA HCT	EQ 150MG BASE;12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022107-002	TEKTURNA HCT	EQ 150MG BASE;25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022107-003	TEKTURNA HCT	EQ 300MG BASE;12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022107-004	TEKTURNA HCT	EQ 300MG BASE;25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022107-001	TEKTURNA HCT	EQ 150MG BASE;12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022107-002	TEKTURNA HCT	EQ 150MG BASE;25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022107-003	TEKTURNA HCT	EQ 300MG BASE;12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022107-004	TEKTURNA HCT	EQ 300MG BASE;25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022107-001	TEKTURNA HCT	EQ 150MG BASE;12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022107-002	TEKTURNA HCT	EQ 150MG BASE;25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022107-003	TEKTURNA HCT	EQ 300MG BASE;12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022107-004	TEKTURNA HCT	EQ 300MG BASE;25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022107-001	TEKTURNA HCT	EQ 150MG BASE;12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022107-002	TEKTURNA HCT	EQ 150MG BASE;25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022107-003	TEKTURNA HCT	EQ 300MG BASE;12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022107-004	TEKTURNA HCT	EQ 300MG BASE;25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022107-001	TEKTURNA HCT	EQ 150MG BASE;12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022107-002	TEKTURNA HCT	EQ 150MG BASE;25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022107-003	TEKTURNA HCT	EQ 300MG BASE;12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022107-004	TEKTURNA HCT	EQ 300MG BASE;25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022107-001	TEKTURNA HCT	EQ 150MG BASE;12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022107-002	TEKTURNA HCT	EQ 150MG BASE;25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022107-003	TEKTURNA HCT	EQ 300MG BASE;12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022107-004	TEKTURNA HCT	EQ 300MG BASE;25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022107-001	TEKTURNA HCT	EQ 150MG BASE;12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022107-002	TEKTURNA HCT	EQ 150MG BASE;25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022107-003	TEKTURNA HCT	EQ 300MG BASE;12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022107-004	TEKTURNA HCT	EQ 300MG BASE;25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022107-001	TEKTURNA HCT	EQ 150MG BASE;12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022107-002	TEKTURNA HCT	EQ 150MG BASE;25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022107-003	TEKTURNA HCT	EQ 300MG BASE;12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022107-004	TEKTURNA HCT	EQ 300MG BASE;25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2008-01-18	`d8e5a09893c0…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 256 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2026-08-18 06:07:40	2026-07	N022107-001	8618172	2028-07-13	Drug product	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022107-002	8618172	2028-07-13	Drug product	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022107-003	8618172	2028-07-13	Drug product	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022107-004	8618172	2028-07-13	Drug product	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022107-001	8618172	2028-07-13	Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022107-002	8618172	2028-07-13	Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022107-003	8618172	2028-07-13	Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022107-004	8618172	2028-07-13	Drug product	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022107-001	8618172	2028-07-13	Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022107-002	8618172	2028-07-13	Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022107-003	8618172	2028-07-13	Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022107-004	8618172	2028-07-13	Drug product	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022107-001	8618172	2028-07-13	Drug product	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022107-002	8618172	2028-07-13	Drug product	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022107-003	8618172	2028-07-13	Drug product	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022107-004	8618172	2028-07-13	Drug product	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022107-001	8618172	2028-07-13	Drug product	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022107-002	8618172	2028-07-13	Drug product	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022107-003	8618172	2028-07-13	Drug product	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022107-004	8618172	2028-07-13	Drug product	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022107-001	8618172	2028-07-13	Drug product	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022107-002	8618172	2028-07-13	Drug product	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022107-003	8618172	2028-07-13	Drug product	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022107-004	8618172	2028-07-13	Drug product	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022107-001	8618172	2028-07-13	Drug product	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022107-002	8618172	2028-07-13	Drug product	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022107-003	8618172	2028-07-13	Drug product	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022107-004	8618172	2028-07-13	Drug product	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022107-001	8618172	2028-07-13	Drug product	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022107-002	8618172	2028-07-13	Drug product	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022107-003	8618172	2028-07-13	Drug product	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022107-004	8618172	2028-07-13	Drug product	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022107-001	8618172	2028-07-13	Drug product	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022107-002	8618172	2028-07-13	Drug product	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022107-003	8618172	2028-07-13	Drug product	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022107-004	8618172	2028-07-13	Drug product	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022107-001	8618172	2028-07-13	Drug product	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022107-002	8618172	2028-07-13	Drug product	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022107-003	8618172	2028-07-13	Drug product	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022107-004	8618172	2028-07-13	Drug product	`d8e5a09893c0…`

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
d42d9045-7020-6e5a-1a1f-b86d9a92bc22	Product name	3	20201015
47fc2fe9-7afb-4be9-989d-787aaa6ad0ea	Product name	1	20200505
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
63ab5fbf-2a6b-c41d-051a-39e845d718b1	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
f5231d08-c52b-a5a0-ba93-675895c292be	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70839-112-01	2024-01-30	C162847	48780-1	1030e365-6576-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use TEKTURNA HCT safely and effectively. See full prescribing information for TEKTURNA HCT. TEKTURNA ® HCT (aliskiren and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 2008
70839-112-30	2024-01-30	C162847	48780-1	1030e365-6576-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use TEKTURNA HCT safely and effectively. See full prescribing information for TEKTURNA HCT. TEKTURNA ® HCT (aliskiren and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 2008
70839-112-90	2024-01-30	C162847	48780-1	1030e365-6576-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use TEKTURNA HCT safely and effectively. See full prescribing information for TEKTURNA HCT. TEKTURNA ® HCT (aliskiren and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 2008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70839-112-01	Tekturna HCT	100 in 1 PACKAGE	TABLET, FILM COATED	100	11
70839-112-01	Tekturna HCT	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	11
70839-112-30	Tekturna HCT	30 in 1 BOTTLE	TABLET, FILM COATED	30	11
70839-112-90	Tekturna HCT	90 in 1 BOTTLE	TABLET, FILM COATED	90	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70839-112-30	EA - Each	70839-112	b5cd84c8-2499-4646-bd84-adafa8e4567c	1	2017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70839-112	TEKTURNA HCT (ALISKIREN HEMIFUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NODEN PHARMA USA, INC.]	11	Legacy NDC, 4 package rows	20221117_8df0ca6a-58cf-41fc-b890-5c7fa5a3792c.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
C8A0P8G029	ALISKIREN HEMIFUMARATE	173334-58-2	ALISKIREN HEMIFUMARATE
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1011710	aliskiren 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	8df0ca6a-58cf-41fc-b890-5c7fa5a3792c	11
1011713	aliskiren 150 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	8df0ca6a-58cf-41fc-b890-5c7fa5a3792c	11
1011750	aliskiren 300 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	8df0ca6a-58cf-41fc-b890-5c7fa5a3792c	11
1011753	aliskiren 300 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	8df0ca6a-58cf-41fc-b890-5c7fa5a3792c	11
1011712	Tekturna HCT 150 MG / 12.5 MG Oral Tablet	PSN	8df0ca6a-58cf-41fc-b890-5c7fa5a3792c	11
1011715	Tekturna HCT 150 MG / 25 MG Oral Tablet	PSN	8df0ca6a-58cf-41fc-b890-5c7fa5a3792c	11
1011752	Tekturna HCT 300 MG / 12.5 MG Oral Tablet	PSN	8df0ca6a-58cf-41fc-b890-5c7fa5a3792c	11
1011755	Tekturna HCT 300 MG / 25 MG Oral Tablet	PSN	8df0ca6a-58cf-41fc-b890-5c7fa5a3792c	11
1011712	aliskiren 150 MG / hydrochlorothiazide 12.5 MG Oral Tablet [Tekturna HCT]	SBD	8df0ca6a-58cf-41fc-b890-5c7fa5a3792c	11
1011715	aliskiren 150 MG / hydrochlorothiazide 25 MG Oral Tablet [Tekturna HCT]	SBD	8df0ca6a-58cf-41fc-b890-5c7fa5a3792c	11
1011752	aliskiren 300 MG / hydrochlorothiazide 12.5 MG Oral Tablet [Tekturna HCT]	SBD	8df0ca6a-58cf-41fc-b890-5c7fa5a3792c	11
1011755	aliskiren 300 MG / hydrochlorothiazide 25 MG Oral Tablet [Tekturna HCT]	SBD	8df0ca6a-58cf-41fc-b890-5c7fa5a3792c	11
1011710	aliskiren 150 MG / hydrochlorothiazide 12.5 MG Oral Tablet	SCD	8df0ca6a-58cf-41fc-b890-5c7fa5a3792c	11
1011713	aliskiren 150 MG / hydrochlorothiazide 25 MG Oral Tablet	SCD	8df0ca6a-58cf-41fc-b890-5c7fa5a3792c	11
1011750	aliskiren 300 MG / hydrochlorothiazide 12.5 MG Oral Tablet	SCD	8df0ca6a-58cf-41fc-b890-5c7fa5a3792c	11
1011753	aliskiren 300 MG / hydrochlorothiazide 25 MG Oral Tablet	SCD	8df0ca6a-58cf-41fc-b890-5c7fa5a3792c	11
1011710	aliskiren 150 MG / HCTZ 12.5 MG Oral Tablet	SY	8df0ca6a-58cf-41fc-b890-5c7fa5a3792c	11
1011712	aliskiren 150 MG / HCTZ 12.5 MG Oral Tablet [Tekturna HCT]	SY	8df0ca6a-58cf-41fc-b890-5c7fa5a3792c	11
1011713	aliskiren 150 MG / HCTZ 25 MG Oral Tablet	SY	8df0ca6a-58cf-41fc-b890-5c7fa5a3792c	11
1011715	aliskiren 150 MG / HCTZ 25 MG Oral Tablet [Tekturna HCT]	SY	8df0ca6a-58cf-41fc-b890-5c7fa5a3792c	11
1011750	aliskiren 300 MG / HCTZ 12.5 MG Oral Tablet	SY	8df0ca6a-58cf-41fc-b890-5c7fa5a3792c	11
1011752	aliskiren 300 MG / HCTZ 12.5 MG Oral Tablet [Tekturna HCT]	SY	8df0ca6a-58cf-41fc-b890-5c7fa5a3792c	11
1011753	aliskiren 300 MG / HCTZ 25 MG Oral Tablet	SY	8df0ca6a-58cf-41fc-b890-5c7fa5a3792c	11
1011755	aliskiren 300 MG / HCTZ 25 MG Oral Tablet [Tekturna HCT]	SY	8df0ca6a-58cf-41fc-b890-5c7fa5a3792c	11
1011712	Tekturna HCT (aliskiren 150 MG / HCTZ 12.5 MG) Oral Tablet	SY	8df0ca6a-58cf-41fc-b890-5c7fa5a3792c	11
1011715	Tekturna HCT (aliskiren 150 MG / HCTZ 25 MG) Oral Tablet	SY	8df0ca6a-58cf-41fc-b890-5c7fa5a3792c	11
1011752	Tekturna HCT (aliskiren 300 MG / HCTZ 12.5 MG) Oral Tablet	SY	8df0ca6a-58cf-41fc-b890-5c7fa5a3792c	11
1011755	Tekturna HCT (aliskiren 300 MG / HCTZ 25 MG) Oral Tablet	SY	8df0ca6a-58cf-41fc-b890-5c7fa5a3792c	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70839-112-01	70839011201	100 in 1 PACKAGE					Historical
70839-112-30	70839011230	30 TABLET, FILM COATED in 1 BOTTLE (70839-112-30)	2017-01-01	0000-00-00	No	No	Current
70839-112-90	70839011290	90 in 1 BOTTLE					Historical