Home NDC 70771-1017 Bosentan
Product NDC 70771-1017
11-digit product format 707711017
Labeler code 70771
Product ID 70771-1017_33935d05-c8ff-4d9e-91bf-fac9072d25fd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bosentan
Dosage form TABLET
Route ORAL
Labeler Zydus Lifesciences Limited
Application ANDA207760
Marketing category ANDA
Marketing start 2019-05-01
Substance BOSENTAN
Active strength 62.5 mg/1
Pharmacologic classes Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], 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 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 A207760-001 BOSENTAN BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 A207760-002 BOSENTAN BOSENTAN 125MG TABLET / ORAL AB 2019-04-26
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 A207760-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207760-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207760-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207760-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207760-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207760-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207760-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207760-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207760-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207760-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207760-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207760-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207760-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207760-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207760-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207760-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207760-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207760-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207760-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207760-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207760-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207760-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207760-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207760-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207760-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207760-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207760-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207760-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207760-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A207760-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207760-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207760-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207760-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A207760-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207760-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A207760-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207760-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A207760-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207760-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A207760-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 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 Bosentan
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BOSENTAN 62.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Q326023R30 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349253 Internal RxNorm lookup 656659 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70771-1017 BOSENTAN TABLET [ZYDUS LIFESCIENCES LIMITED] 6 Current NDC, Legacy NDC, 6 package rows 20241128_02892f47-0d59-4254-9ee7-d524278fdd79.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 Units Marketing start Marketing end Sample Exclude flag Status 70771-1017-1 70771101701 100 TABLET in 1 BOTTLE (70771-1017-1) 100 tablet 2019-05-01 0000-00-00 No No Current 70771-1017-2 70771101702 10 in 1 BLISTER PACK Historical 70771-1017-4 70771101704 10 BLISTER PACK in 1 CARTON (70771-1017-4) / 10 TABLET in 1 BLISTER PACK (70771-1017-2) 10 blister pack 2019-05-01 0000-00-00 No No Current 70771-1017-5 70771101705 500 TABLET in 1 BOTTLE (70771-1017-5) 500 tablet 2019-05-01 0000-00-00 No No Current 70771-1017-6 70771101706 60 TABLET in 1 BOTTLE (70771-1017-6) 60 tablet 2019-05-01 0000-00-00 No No Current 70771-1017-8 70771101708 180 TABLET in 1 BOTTLE (70771-1017-8) 180 tablet 2019-05-01 0000-00-00 No No Current