Home NDC 49884-424 ALISKIREN
Product NDC 49884-424
11-digit product format 498840424
Labeler code 49884
Product ID 49884-424_6c3a1f0c-dd67-4849-a8b5-a88f85ac5f43
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ALISKIREN
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Endo USA, Inc.
Application ANDA206665
Marketing category ANDA
Marketing start 2019-03-25
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 A206665-001 ALISKIREN HEMIFUMARATE ALISKIREN HEMIFUMARATE EQ 150MG BASE TABLET / ORAL AB 2019-03-22 A206665-002 ALISKIREN HEMIFUMARATE ALISKIREN HEMIFUMARATE EQ 300MG BASE TABLET / ORAL AB 2019-03-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 A206665-001 ALISKIREN HEMIFUMARATE EQ 150MG BASE TABLET / ORAL AB 2019-03-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206665-002 ALISKIREN HEMIFUMARATE EQ 300MG BASE TABLET / ORAL AB 2019-03-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206665-001 ALISKIREN HEMIFUMARATE EQ 150MG BASE TABLET / ORAL AB 2019-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206665-002 ALISKIREN HEMIFUMARATE EQ 300MG BASE TABLET / ORAL AB 2019-03-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206665-001 ALISKIREN HEMIFUMARATE EQ 150MG BASE TABLET / ORAL AB 2019-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206665-002 ALISKIREN HEMIFUMARATE EQ 300MG BASE TABLET / ORAL AB 2019-03-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206665-001 ALISKIREN HEMIFUMARATE EQ 150MG BASE TABLET / ORAL AB 2019-03-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206665-002 ALISKIREN HEMIFUMARATE EQ 300MG BASE TABLET / ORAL AB 2019-03-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206665-001 ALISKIREN HEMIFUMARATE EQ 150MG BASE TABLET / ORAL AB 2019-03-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206665-002 ALISKIREN HEMIFUMARATE EQ 300MG BASE TABLET / ORAL AB 2019-03-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206665-001 ALISKIREN HEMIFUMARATE EQ 150MG BASE TABLET / ORAL AB 2019-03-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206665-002 ALISKIREN HEMIFUMARATE EQ 300MG BASE TABLET / ORAL AB 2019-03-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206665-001 ALISKIREN HEMIFUMARATE EQ 150MG BASE TABLET / ORAL AB 2019-03-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206665-002 ALISKIREN HEMIFUMARATE EQ 300MG BASE TABLET / ORAL AB 2019-03-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206665-001 ALISKIREN HEMIFUMARATE EQ 150MG BASE TABLET / ORAL AB 2019-03-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206665-002 ALISKIREN HEMIFUMARATE EQ 300MG BASE TABLET / ORAL AB 2019-03-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206665-001 ALISKIREN HEMIFUMARATE EQ 150MG BASE TABLET / ORAL AB 2019-03-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206665-002 ALISKIREN HEMIFUMARATE EQ 300MG BASE TABLET / ORAL AB 2019-03-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206665-001 ALISKIREN HEMIFUMARATE EQ 150MG BASE TABLET / ORAL AB 2019-03-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206665-002 ALISKIREN HEMIFUMARATE EQ 300MG BASE TABLET / ORAL AB 2019-03-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206665-001 ALISKIREN HEMIFUMARATE EQ 150MG BASE TABLET / ORAL AB 2019-03-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206665-002 ALISKIREN HEMIFUMARATE EQ 300MG BASE TABLET / ORAL AB 2019-03-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206665-001 ALISKIREN HEMIFUMARATE EQ 150MG BASE TABLET / ORAL AB 2019-03-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206665-002 ALISKIREN HEMIFUMARATE EQ 300MG BASE TABLET / ORAL AB 2019-03-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206665-001 ALISKIREN HEMIFUMARATE EQ 150MG BASE TABLET / ORAL AB 2019-03-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206665-002 ALISKIREN HEMIFUMARATE EQ 300MG BASE TABLET / ORAL AB 2019-03-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206665-001 ALISKIREN HEMIFUMARATE EQ 150MG BASE TABLET / ORAL AB 2019-03-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206665-002 ALISKIREN HEMIFUMARATE EQ 300MG BASE TABLET / ORAL AB 2019-03-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206665-001 ALISKIREN HEMIFUMARATE EQ 150MG BASE TABLET / ORAL AB 2019-03-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206665-002 ALISKIREN HEMIFUMARATE EQ 300MG BASE TABLET / ORAL AB 2019-03-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206665-001 ALISKIREN HEMIFUMARATE EQ 150MG BASE TABLET / ORAL AB 2019-03-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206665-002 ALISKIREN HEMIFUMARATE EQ 300MG BASE TABLET / ORAL AB 2019-03-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206665-001 ALISKIREN HEMIFUMARATE EQ 150MG BASE TABLET / ORAL AB 2019-03-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A206665-002 ALISKIREN HEMIFUMARATE EQ 300MG BASE TABLET / ORAL AB 2019-03-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206665-001 ALISKIREN HEMIFUMARATE EQ 150MG BASE TABLET / ORAL AB 2019-03-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A206665-002 ALISKIREN HEMIFUMARATE EQ 300MG BASE TABLET / ORAL AB 2019-03-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206665-001 ALISKIREN HEMIFUMARATE EQ 150MG BASE TABLET / ORAL AB 2019-03-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A206665-002 ALISKIREN HEMIFUMARATE EQ 300MG BASE TABLET / ORAL AB 2019-03-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206665-001 ALISKIREN HEMIFUMARATE EQ 150MG BASE TABLET / ORAL AB 2019-03-22 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A206665-002 ALISKIREN HEMIFUMARATE EQ 300MG BASE TABLET / ORAL AB 2019-03-22 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base ALISKIREN
Listing expiration 2027-12-31 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 49884-424-11 ALISKIREN 30 in 1 BOTTLE TABLET, FILM COATED 30 29
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49884-424 ALISKIREN TABLET, FILM COATED [ENDO USA, INC.] 29 Current NDC, Legacy NDC, 1 package rows 20240926_f3fd2503-25ef-4660-a29a-f62c491e28fb.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 · 1 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 49884-424-11 49884042411 30 TABLET, FILM COATED in 1 BOTTLE (49884-424-11) 2019-03-25 0000-00-00 No No Current