Home NDC 66993-141 Aliskiren
Product NDC 66993-141
11-digit product format 669930141
Labeler code 66993
Product ID 66993-141_9a21dde8-cd39-400b-933a-a74e907ffcba
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name aliskiren hemifumarate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Prasco Laboratories
Application NDA021985
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2019-03-04
Substance ALISKIREN HEMIFUMARATE
Active strength 150 mg/1
Pharmacologic classes Renin Inhibitor [EPC], Renin Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 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…
Additional Listing Data#
Finished product Yes
Brand name base Aliskiren
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALISKIREN HEMIFUMARATE 150 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1011736 Internal RxNorm lookup 1011739 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66993-141-30 Aliskiren 30 in 1 BOTTLE TABLET, FILM COATED 30 18
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66993-141 ALISKIREN (ALISKIREN HEMIFUMARATE) TABLET, FILM COATED [PRASCO LABORATORIES] 18 Current NDC, Legacy NDC, 1 package rows 20240717_41c0e5e0-eb26-4d9e-bcd2-d0f2cc8fc6db.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 66993-141-30 66993014130 30 TABLET, FILM COATED in 1 BOTTLE (66993-141-30) 2019-03-04 0000-00-00 No No Current