Home NDC 68180-340 Bosentan
Product NDC 68180-340
11-digit product format 681800340
Labeler code 68180
Product ID 68180-340_063d2028-f666-4304-8cd3-21d882d8c97f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bosentan
Dosage form TABLET, FOR SUSPENSION
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA213154
Marketing category ANDA
Marketing start 2025-08-18
Substance BOSENTAN
Active strength 32 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213154-001 BOSENTAN BOSENTAN 32MG TABLET, FOR SUSPENSION / ORAL AB 2025-02-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213154-001 AB
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration A213154-001 PC 2026-02-14
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.
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 A213154-001 BOSENTAN 32MG TABLET, FOR SUSPENSION / ORAL AB 2025-02-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213154-001 BOSENTAN 32MG TABLET, FOR SUSPENSION / ORAL AB 2025-02-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213154-001 BOSENTAN 32MG TABLET, FOR SUSPENSION / ORAL AB 2025-02-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213154-001 BOSENTAN 32MG TABLET, FOR SUSPENSION / ORAL AB 2025-02-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213154-001 BOSENTAN 32MG TABLET, FOR SUSPENSION / ORAL AB 2025-02-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213154-001 BOSENTAN 32MG TABLET, FOR SUSPENSION / ORAL AB 2025-02-05 b8a1b40f171c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213154-001 BOSENTAN 32MG TABLET, FOR SUSPENSION / ORAL AB 2025-02-05 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-08-18 06:07:40 2026-07 A213154-001 PC 2026-02-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213154-001 PC 2026-02-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213154-001 PC 2026-02-14 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213154-001 PC 2026-02-14 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Bosentan
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BOSENTAN 32 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1989081 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 68180-340-13 Bosentan 14 in 1 BLISTER PACK TABLET, FOR SUSPENSION 14 7 68180-340-13 Bosentan 4 in 1 CARTON TABLET, FOR SUSPENSION 4 7 68180-340-74 Bekyree 5 in 1 BLISTER PACK TABLET, FILM COATED 5 0.01 mg 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-340 BEKYREE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 4 Current NDC 20230322_f1fcfd58-880d-4023-b48a-67e87c094f37.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 Units Marketing start Sample Exclude flag Status 68180-340-13 68180034013 4 BLISTER PACK in 1 CARTON (68180-340-13) / 14 TABLET, FOR SUSPENSION in 1 BLISTER PACK 4 blister pack 2025-08-18 No No Current 68180-340-74 68180034074 5 in 1 BLISTER PACK Historical