Home NDC 42794-051 AMBRISENTAN
Product NDC 42794-051
11-digit product format 427940051
Labeler code 42794
Product ID 42794-051_f1f20771-a78f-74cf-e053-2995a90a6adf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name AMBRISENTAN
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sigmapharm Laboratories, LLC
Application ANDA208354
Marketing category ANDA
Marketing start 2019-04-10
Substance AMBRISENTAN
Active strength 5 mg/1
Pharmacologic classes Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [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 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.
Additional Listing Data#
Finished product Yes
Brand name base AMBRISENTAN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMBRISENTAN 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination HW6NV07QEC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 722116 Internal RxNorm lookup 722122 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 42794-051-08 AMBRISENTAN 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 7 42794-051-22 AMBRISENTAN 10 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 10 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42794-051 AMBRISENTAN TABLET, FILM COATED [SIGMAPHARM LABORATORIES, LLC] 7 Current NDC, Legacy NDC, 2 package rows 20230111_e20ab2fe-bc9f-48a3-b15a-e4bc9532c2ac.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 42794-051-08 42794005108 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42794-051-08) 2019-04-10 0000-00-00 No No Current 42794-051-22 42794005122 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42794-051-22) 2019-04-10 0000-00-00 No No Current