Home NDC 0591-2512-60 bosentan
Product NDC 0591-2512
Requested package NDC 0591-2512-60
11-digit product format 005912512
Labeler code 0591
Product ID 0591-2512_b40e9d96-1700-4b99-bd19-29d53706231c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bosentan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA207110
Marketing category ANDA
Marketing start 2019-06-19
Substance BOSENTAN
Active strength 125 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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A207110-001 BOSENTAN BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 A207110-002 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 · 86 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 2026-09-14 22:38:34 2026-08 A207110-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207110-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207110-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207110-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207110-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207110-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207110-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207110-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207110-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207110-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207110-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207110-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207110-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207110-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207110-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207110-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207110-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207110-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207110-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207110-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207110-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207110-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207110-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207110-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207110-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207110-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207110-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207110-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207110-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207110-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207110-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A207110-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207110-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207110-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207110-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A207110-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207110-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A207110-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207110-001 BOSENTAN 62.5MG TABLET / ORAL AB 2019-04-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A207110-002 BOSENTAN 125MG TABLET / ORAL AB 2019-04-26 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base bosentan
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BOSENTAN 125 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 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 0591-2512-60 bosentan 60 in 1 BOTTLE TABLET, FILM COATED 60 24
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-2512 BOSENTAN TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 20 Current NDC, Legacy NDC, 1 package rows 20240423_39b2a85f-4322-42d4-b420-1b1d52569143.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 0591-2512-60 00591251260 60 TABLET, FILM COATED in 1 BOTTLE (0591-2512-60) 2019-06-19 0000-00-00 No No Current