Home NDC 70710-1508 bosentan
Product NDC 70710-1508
11-digit product format 707101508
Labeler code 70710
Product ID 70710-1508_a4b3663e-948c-4d0d-9916-237b5597ad9f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bosentan
Dosage form TABLET, FOR SUSPENSION
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA213981
Marketing category ANDA
Marketing start 2026-02-17
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 2027-12-31
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 A213981-001 BOSENTAN BOSENTAN 32MG TABLET, FOR SUSPENSION / ORAL AB 2026-02-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213981-001 AB
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 A213981-001 BOSENTAN 32MG TABLET, FOR SUSPENSION / ORAL AB 2026-02-17 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213981-001 BOSENTAN 32MG TABLET, FOR SUSPENSION / ORAL AB 2026-02-17 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-18 06:07:40 2026-07 A213981-001 AB 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213981-001 AB 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base bosentan
Listing expiration 2027-12-31 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 70710-1508-7 bosentan 14 in 1 BLISTER PACK TABLET, FOR SUSPENSION 14 1 70710-1508-8 bosentan 4 in 1 CARTON TABLET, FOR SUSPENSION 4 1
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 Sample Exclude flag Status 70710-1508-7 70710150807 14 in 1 BLISTER PACK Historical 70710-1508-8 70710150808 4 BLISTER PACK in 1 CARTON (70710-1508-8) / 14 TABLET, FOR SUSPENSION in 1 BLISTER PACK (70710-1508-7) 4 blister pack 2026-02-17 No No Current