Home NDC 50090-1250 Tekturna
Product NDC 50090-1250
11-digit product format 500901250
Labeler code 50090
Product ID 50090-1250_ee935dc7-22f5-48a5-9fd9-792b8d1de27f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name aliskiren hemifumarate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler A-S Medication Solutions
Application NDA021985
Marketing category NDA
Marketing start 2007-03-05
Marketing end 0000-00-00
Substance ALISKIREN HEMIFUMARATE
Active strength 300 mg/1
Pharmacologic classes Renin Inhibitor [EPC],Renin Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50090-1250-0 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50090-1250-0 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50090-1250-0 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50090-1250-0 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50090-1250-0 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50090-1250-0 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50090-1250-0 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50090-1250-0 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50090-1250-0 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50090-1250-0 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50090-1250-0 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50090-1250-0 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.
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date 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.
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 Use code Coverage / status Submission date 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…
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.