Home NDC 0378-0606 Macitentan
Product NDC 0378-0606
11-digit product format 003780606
Labeler code 0378
Product ID 0378-0606_d88a13e7-cf08-4632-86be-dcd979516296
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Macitentan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA211161
Marketing category ANDA
Marketing start 2026-06-08
Substance MACITENTAN
Active strength 10 mg/1
Pharmacologic classes 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211161-001 MACITENTAN MACITENTAN 10MG TABLET / ORAL AB 2025-12-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211161-001 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 2026-09-14 22:38:34 2026-08 A211161-001 MACITENTAN 10MG TABLET / ORAL AB 2025-12-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211161-001 MACITENTAN 10MG TABLET / ORAL AB 2025-12-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211161-001 MACITENTAN 10MG TABLET / ORAL 2025-12-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211161-001 MACITENTAN 10MG TABLET / ORAL AB 2025-12-03 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211161-001 MACITENTAN 10MG TABLET / ORAL AB 2025-12-03 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A211161-001 AB 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211161-001 AB 1 caaa826d4ba7…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211161-001 AB 1 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211161-001 AB 1 a50c72e98297…
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 Macitentan
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MACITENTAN 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Z9K9Y9WMVL Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1442137 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0378-0606-93 00378060693 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0606-93) 2026-06-08 No No Current