Home NDC 68180-387 Bosentan
Product NDC 68180-387
11-digit product format 681800387
Labeler code 68180
Product ID 68180-387_7dd72f02-4300-434a-a67c-f6ab1cff4991
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bosentan
Dosage form TABLET
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA206987
Marketing category ANDA
Marketing start 2019-04-26
Marketing end 0000-00-00
Substance BOSENTAN
Active strength 63 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 2024-12-31
Current FDA listing Historical FDA.report record 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 A206987-001 BOSENTAN BOSENTAN 62.5MG TABLET / ORAL 2019-04-26 A206987-002 BOSENTAN BOSENTAN 125MG TABLET / ORAL 2019-04-26
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 A206987-001 BOSENTAN 62.5MG TABLET / ORAL 2019-04-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206987-002 BOSENTAN 125MG TABLET / ORAL 2019-04-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206987-001 BOSENTAN 62.5MG TABLET / ORAL 2019-04-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206987-002 BOSENTAN 125MG TABLET / ORAL 2019-04-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206987-001 BOSENTAN 62.5MG TABLET / ORAL 2019-04-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206987-002 BOSENTAN 125MG TABLET / ORAL 2019-04-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206987-001 BOSENTAN 62.5MG TABLET / ORAL 2019-04-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206987-002 BOSENTAN 125MG TABLET / ORAL 2019-04-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206987-001 BOSENTAN 62.5MG TABLET / ORAL 2019-04-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206987-002 BOSENTAN 125MG TABLET / ORAL 2019-04-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206987-001 BOSENTAN 62.5MG TABLET / ORAL 2019-04-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206987-002 BOSENTAN 125MG TABLET / ORAL 2019-04-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206987-001 BOSENTAN 62.5MG TABLET / ORAL 2019-04-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206987-002 BOSENTAN 125MG TABLET / ORAL 2019-04-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206987-001 BOSENTAN 62.5MG TABLET / ORAL 2019-04-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206987-002 BOSENTAN 125MG TABLET / ORAL 2019-04-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206987-001 BOSENTAN 62.5MG TABLET / ORAL 2019-04-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206987-002 BOSENTAN 125MG TABLET / ORAL 2019-04-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206987-001 BOSENTAN 62.5MG TABLET / ORAL 2019-04-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206987-002 BOSENTAN 125MG TABLET / ORAL 2019-04-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206987-001 BOSENTAN 62.5MG TABLET / ORAL 2019-04-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206987-002 BOSENTAN 125MG TABLET / ORAL 2019-04-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206987-001 BOSENTAN 62.5MG TABLET / ORAL 2019-04-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206987-002 BOSENTAN 125MG TABLET / ORAL 2019-04-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206987-001 BOSENTAN 62.5MG TABLET / ORAL 2019-04-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206987-002 BOSENTAN 125MG TABLET / ORAL 2019-04-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206987-001 BOSENTAN 62.5MG TABLET / ORAL 2019-04-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206987-002 BOSENTAN 125MG TABLET / ORAL 2019-04-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206987-001 BOSENTAN 62.5MG TABLET / ORAL 2019-04-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206987-002 BOSENTAN 125MG TABLET / ORAL 2019-04-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206987-001 BOSENTAN 62.5MG TABLET / ORAL 2019-04-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206987-002 BOSENTAN 125MG TABLET / ORAL 2019-04-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206987-001 BOSENTAN 62.5MG TABLET / ORAL 2019-04-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A206987-002 BOSENTAN 125MG TABLET / ORAL 2019-04-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206987-001 BOSENTAN 62.5MG TABLET / ORAL 2019-04-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A206987-002 BOSENTAN 125MG TABLET / ORAL 2019-04-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206987-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A206987-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206987-001 BOSENTAN 62.5MG TABLET / ORAL 2019-04-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A206987-002 BOSENTAN 125MG TABLET / ORAL 2019-04-26 bb7c543d1eb4…
Observed Orange Book normalized TE history# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68180-387-07 68180038707 60 TABLET in 1 BOTTLE (68180-387-07) 60 tablet 2019-04-26 0000-00-00 No No Current