Home NDC 68382-446 Bosentan
Product NDC 68382-446
11-digit product format 683820446
Labeler code 68382
Product ID 68382-446_f6180792-cb7a-46ef-b2bb-4a819e4901bb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bosentan
Dosage form TABLET, COATED
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
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 2027-12-31 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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68382-446-01 Bosentan 100 in 1 BOTTLE TABLET, COATED 100 7 68382-446-05 Bosentan 500 in 1 BOTTLE TABLET, COATED 500 7 68382-446-14 Bosentan 60 in 1 BOTTLE TABLET, COATED 60 7 68382-446-28 Bosentan 180 in 1 BOTTLE TABLET, COATED 180 7 68382-446-30 Bosentan 10 in 1 BLISTER PACK TABLET, COATED 10 7 68382-446-77 Bosentan 10 in 1 CARTON TABLET, COATED 10 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68382-446 BOSENTAN TABLET, COATED [ZYDUS PHARMACEUTICALS USA INC.] 5 Current NDC, Legacy NDC, 6 package rows 20240229_8444da17-6c31-492b-8842-93740f083d9d.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68382-446-01 68382044601 100 TABLET, COATED in 1 BOTTLE (68382-446-01) 2019-05-01 0000-00-00 No No Current 68382-446-05 68382044605 500 TABLET, COATED in 1 BOTTLE (68382-446-05) 2019-05-01 0000-00-00 No No Current 68382-446-14 68382044614 60 TABLET, COATED in 1 BOTTLE (68382-446-14) 2019-05-01 0000-00-00 No No Current 68382-446-28 68382044628 180 TABLET, COATED in 1 BOTTLE (68382-446-28) 2019-05-01 0000-00-00 No No Current 68382-446-30 68382044630 10 in 1 BLISTER PACK Historical 68382-446-77 68382044677 10 BLISTER PACK in 1 CARTON (68382-446-77) / 10 TABLET, COATED in 1 BLISTER PACK (68382-446-30) 10 blister pack 2019-05-01 0000-00-00 No No Current