Tekturna

Product NDC: 70839-300
11-digit product format: 708390300
Labeler code: 70839
Product ID: 70839-300_130d24ec-4b3b-0978-e063-6394a90af0c8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: aliskiren hemifumarate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: LXO US Inc.
Application: NDA021985
Marketing category: NDA
Marketing start: 2007-03-05
Substance: ALISKIREN HEMIFUMARATE
Active strength: 300 mg/1
Pharmacologic classes: Renin Inhibitor [EPC], Renin Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	70839-300	70839-300-01	D	Discontinued by firm	2026-08-17
excluded package	package	70839-300	70839-300-90	D	Discontinued by firm	2026-08-17
excluded package	package	70839-300	70839-300-99	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 · 36 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	70839-300-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	70839-300-99	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	70839-300-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	70839-300-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	70839-300-99	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	70839-300-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	70839-300-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	70839-300-99	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	70839-300-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	70839-300-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	70839-300-99	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	70839-300-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	70839-300-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	70839-300-99	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	70839-300-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	70839-300-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	70839-300-99	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	70839-300-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	70839-300-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	70839-300-99	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	70839-300-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	70839-300-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	70839-300-99	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	70839-300-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	70839-300-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	70839-300-99	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	70839-300-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	70839-300-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	70839-300-99	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	70839-300-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	70839-300-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	70839-300-99	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	70839-300-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	70839-300-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	70839-300-99	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	70839-300-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

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
N021985-001	TEKTURNA	ALISKIREN HEMIFUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05
N021985-002	TEKTURNA	ALISKIREN HEMIFUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N021985-001	AB
N021985-002	AB

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status
N021985-001	8617595	2026-02-19	Drug product
N021985-001	8617595*PED	2026-08-19	Pediatric extension
N021985-002	8617595	2026-02-19	Drug product
N021985-002	8617595*PED	2026-08-19	Pediatric extension

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021985-001	TEKTURNA	EQ 150MG BASE	TABLET / ORAL	AB	RLD	2007-03-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021985-002	TEKTURNA	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-05	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	N021985-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021985-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021985-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021985-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021985-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021985-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021985-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021985-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021985-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021985-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021985-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021985-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021985-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021985-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021985-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021985-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021985-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021985-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021985-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021985-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021985-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021985-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021985-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021985-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021985-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021985-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021985-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021985-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021985-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021985-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021985-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021985-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021985-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021985-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021985-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021985-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021985-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021985-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021985-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021985-002	AB	1	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 176 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	N021985-001	8617595	2026-02-19	Drug product	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021985-001	8617595*PED	2026-08-19	Pediatric extension	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021985-002	8617595	2026-02-19	Drug product	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021985-002	8617595*PED	2026-08-19	Pediatric extension	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021985-001	8617595	2026-02-19	Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021985-001	8617595*PED	2026-08-19	Pediatric extension	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021985-002	8617595	2026-02-19	Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021985-002	8617595*PED	2026-08-19	Pediatric extension	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021985-001	8617595	2026-02-19	Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021985-001	8617595*PED	2026-08-19	Pediatric extension	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021985-002	8617595	2026-02-19	Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021985-002	8617595*PED	2026-08-19	Pediatric extension	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021985-001	8617595	2026-02-19	Drug product	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021985-001	8617595*PED	2026-08-19	Pediatric extension	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021985-002	8617595	2026-02-19	Drug product	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021985-002	8617595*PED	2026-08-19	Pediatric extension	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021985-001	8617595	2026-02-19	Drug product	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021985-001	8617595*PED	2026-08-19	Pediatric extension	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021985-002	8617595	2026-02-19	Drug product	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021985-002	8617595*PED	2026-08-19	Pediatric extension	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021985-001	8617595	2026-02-19	Drug product	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021985-001	8617595*PED	2026-08-19	Pediatric extension	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021985-002	8617595	2026-02-19	Drug product	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021985-002	8617595*PED	2026-08-19	Pediatric extension	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021985-001	8617595	2026-02-19	Drug product	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021985-001	8617595*PED	2026-08-19	Pediatric extension	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021985-002	8617595	2026-02-19	Drug product	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021985-002	8617595*PED	2026-08-19	Pediatric extension	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021985-001	8617595	2026-02-19	Drug product	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021985-001	8617595*PED	2026-08-19	Pediatric extension	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021985-002	8617595	2026-02-19	Drug product	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021985-002	8617595*PED	2026-08-19	Pediatric extension	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021985-001	8617595	2026-02-19	Drug product	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021985-001	8617595*PED	2026-08-19	Pediatric extension	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021985-002	8617595	2026-02-19	Drug product	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021985-002	8617595*PED	2026-08-19	Pediatric extension	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021985-001	8617595	2026-02-19	Drug product	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021985-001	8617595*PED	2026-08-19	Pediatric extension	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021985-002	8617595	2026-02-19	Drug product	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021985-002	8617595*PED	2026-08-19	Pediatric extension	`d8e5a09893c0…`

Additional Listing Data#

Finished product: Yes
Brand name base: Tekturna
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALISKIREN HEMIFUMARATE	300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
C8A0P8G029	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1011736	Internal RxNorm lookup
1011738	Internal RxNorm lookup
1011739	Internal RxNorm lookup
1011741	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
3dd61fa5-1620-4ebf-bbdb-ede29b92fce2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d42d9045-7020-6e5a-1a1f-b86d9a92bc22	Product name	3	20201015
63ab5fbf-2a6b-c41d-051a-39e845d718b1	Product name	1	20140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212	Product name	1	20140508
df89bd47-2db4-d593-ab37-d11953fd5536	Product name	1	20140508
f5231d08-c52b-a5a0-ba93-675895c292be	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70839-300-01	Tekturna	100 in 1 PACKAGE	TABLET, FILM COATED	100	16
70839-300-01	Tekturna	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	16
70839-300-30	Tekturna	30 in 1 BOTTLE	TABLET, FILM COATED	30	16
70839-300-90	Tekturna	90 in 1 BOTTLE	TABLET, FILM COATED	90	16
70839-300-99	Tekturna	7 in 1 BOTTLE	TABLET, FILM COATED	7	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70839-300-30	EA - Each	70839-300	bf9f9c5f-91dc-4e05-9378-b28d3f057d58	1	2017-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70839-300	TEKTURNA (ALISKIREN HEMIFUMARATE) TABLET, FILM COATED [LXO US INC.]	16	Current NDC, Legacy NDC, 5 package rows	20240312_3dd61fa5-1620-4ebf-bbdb-ede29b92fce2.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tekturna	ALISKIREN HEMIFUMARATE	LXO US Inc.	3dd61fa5-1620-4ebf-bbdb-ede29b92fce2	2024-03-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021985 application number: NDA021985 ndc (product): 70839-300
Aliskiren	ALISKIREN HEMIFUMARATE	Prasco Laboratories	41c0e5e0-eb26-4d9e-bcd2-d0f2cc8fc6db	2023-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021985 application number: NDA021985

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
C8A0P8G029	ALISKIREN HEMIFUMARATE	173334-58-2	ALISKIREN HEMIFUMARATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1011736	aliskiren 150 MG Oral Tablet	PSN	3dd61fa5-1620-4ebf-bbdb-ede29b92fce2	16
1011739	aliskiren 300 MG Oral Tablet	PSN	3dd61fa5-1620-4ebf-bbdb-ede29b92fce2	16
1011738	Tekturna 150 MG Oral Tablet	PSN	3dd61fa5-1620-4ebf-bbdb-ede29b92fce2	16
1011741	Tekturna 300 MG Oral Tablet	PSN	3dd61fa5-1620-4ebf-bbdb-ede29b92fce2	16
1011738	aliskiren 150 MG Oral Tablet [Tekturna]	SBD	3dd61fa5-1620-4ebf-bbdb-ede29b92fce2	16
1011741	aliskiren 300 MG Oral Tablet [Tekturna]	SBD	3dd61fa5-1620-4ebf-bbdb-ede29b92fce2	16
1011736	aliskiren 150 MG Oral Tablet	SCD	3dd61fa5-1620-4ebf-bbdb-ede29b92fce2	16
1011739	aliskiren 300 MG Oral Tablet	SCD	3dd61fa5-1620-4ebf-bbdb-ede29b92fce2	16
1011736	aliskiren (as aliskiren fumarate) 150 MG Oral Tablet	SY	3dd61fa5-1620-4ebf-bbdb-ede29b92fce2	16
1011739	aliskiren (as aliskiren fumarate) 300 MG Oral Tablet	SY	3dd61fa5-1620-4ebf-bbdb-ede29b92fce2	16
1011738	Tekturna 150 MG Oral Tablet	SY	3dd61fa5-1620-4ebf-bbdb-ede29b92fce2	16
1011741	Tekturna 300 MG Oral Tablet	SY	3dd61fa5-1620-4ebf-bbdb-ede29b92fce2	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70839-300-01	70839030001	100 in 1 PACKAGE					Historical
70839-300-30	70839030030	30 TABLET, FILM COATED in 1 BOTTLE (70839-300-30)	2017-01-01	0000-00-00	No	No	Current
70839-300-90	70839030090	90 in 1 BOTTLE					Historical
70839-300-99	70839030099	7 in 1 BOTTLE					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tekturna	LXO US Inc. \| Packaging Coordinators, LLC \| Delpharm Milano S.r.l.	2024-03-07	HUMAN PRESCRIPTION DRUG LABEL	16
TEKTURNA	A-S Medication Solutions	2024-02-13	HUMAN PRESCRIPTION DRUG LABEL	13