Home NDC 42291-018-30 AMBRISENTAN
Product NDC 42291-018
Requested package NDC 42291-018-30
11-digit product format 422910018
Labeler code 42291
Product ID 42291-018_b6c019e2-3f31-061d-e053-2a95a90a89d3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name AMBRISENTAN
Dosage form TABLET, FILM COATED
Route ORAL
Labeler AvKARE
Application ANDA208354
Marketing category ANDA
Marketing start 2020-12-18
Marketing end 0000-00-00
Substance AMBRISENTAN
Active strength 5 mg/1
Pharmacologic classes Endothelin Receptor Antagonist [EPC],Endothelin Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2021-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A208354-001 AMBRISENTAN AMBRISENTAN 5MG TABLET / ORAL AB 2019-04-10 A208354-002 AMBRISENTAN AMBRISENTAN 10MG TABLET / ORAL AB 2019-04-10
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 · 82 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 2026-02-19 14:30 UTC 2026-02 A208354-001 AMBRISENTAN 5MG TABLET / ORAL AB 2019-04-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208354-002 AMBRISENTAN 10MG TABLET / ORAL AB 2019-04-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208354-001 AMBRISENTAN 5MG TABLET / ORAL AB 2019-04-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208354-002 AMBRISENTAN 10MG TABLET / ORAL AB 2019-04-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208354-001 AMBRISENTAN 5MG TABLET / ORAL AB 2019-04-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208354-002 AMBRISENTAN 10MG TABLET / ORAL AB 2019-04-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208354-001 AMBRISENTAN 5MG TABLET / ORAL AB 2019-04-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208354-002 AMBRISENTAN 10MG TABLET / ORAL AB 2019-04-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208354-001 AMBRISENTAN 5MG TABLET / ORAL AB 2019-04-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208354-002 AMBRISENTAN 10MG TABLET / ORAL AB 2019-04-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208354-001 AMBRISENTAN 5MG TABLET / ORAL AB 2019-04-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208354-002 AMBRISENTAN 10MG TABLET / ORAL AB 2019-04-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208354-001 AMBRISENTAN 5MG TABLET / ORAL AB 2019-04-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208354-002 AMBRISENTAN 10MG TABLET / ORAL AB 2019-04-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208354-001 AMBRISENTAN 5MG TABLET / ORAL AB 2019-04-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208354-002 AMBRISENTAN 10MG TABLET / ORAL AB 2019-04-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208354-001 AMBRISENTAN 5MG TABLET / ORAL AB 2019-04-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208354-002 AMBRISENTAN 10MG TABLET / ORAL AB 2019-04-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208354-001 AMBRISENTAN 5MG TABLET / ORAL AB 2019-04-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208354-002 AMBRISENTAN 10MG TABLET / ORAL AB 2019-04-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208354-001 AMBRISENTAN 5MG TABLET / ORAL AB 2019-04-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208354-002 AMBRISENTAN 10MG TABLET / ORAL AB 2019-04-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208354-001 AMBRISENTAN 5MG TABLET / ORAL AB 2019-04-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208354-002 AMBRISENTAN 10MG TABLET / ORAL AB 2019-04-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208354-001 AMBRISENTAN 5MG TABLET / ORAL AB 2019-04-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208354-002 AMBRISENTAN 10MG TABLET / ORAL AB 2019-04-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208354-001 AMBRISENTAN 5MG TABLET / ORAL AB 2019-04-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208354-002 AMBRISENTAN 10MG TABLET / ORAL AB 2019-04-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208354-001 AMBRISENTAN 5MG TABLET / ORAL AB 2019-04-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208354-002 AMBRISENTAN 10MG TABLET / ORAL AB 2019-04-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208354-001 AMBRISENTAN 5MG TABLET / ORAL AB 2019-04-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A208354-002 AMBRISENTAN 10MG TABLET / ORAL AB 2019-04-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208354-001 AMBRISENTAN 5MG TABLET / ORAL AB 2019-04-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A208354-002 AMBRISENTAN 10MG TABLET / ORAL AB 2019-04-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208354-001 AMBRISENTAN 5MG TABLET / ORAL AB 2019-04-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A208354-002 AMBRISENTAN 10MG TABLET / ORAL AB 2019-04-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208354-001 AMBRISENTAN 5MG TABLET / ORAL AB 2019-04-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A208354-002 AMBRISENTAN 10MG TABLET / ORAL AB 2019-04-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208354-001 AMBRISENTAN 5MG TABLET / ORAL AB 2019-04-10 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A208354-002 AMBRISENTAN 10MG TABLET / ORAL AB 2019-04-10 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join AMBRISENTAN AMBRISENTAN Sigmapharm Laboratories, LLC e20ab2fe-bc9f-48a3-b15a-e4bc9532c2ac 2023-01-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208354 application number: ANDA208354
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 42291-018-30 42291001830 30 TABLET, FILM COATED in 1 BOTTLE (42291-018-30) 2020-12-18 0000-00-00 No No Current