Home NDC 66215-501 OPSUMIT
Product NDC 66215-501
11-digit product format 662150501
Labeler code 66215
Product ID 66215-501_3282790e-e454-3214-e063-6294a90a526b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name macitentan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Actelion Pharmaceuticals US, Inc.
Application NDA204410
Marketing category NDA
Marketing start 2013-11-04
Substance MACITENTAN
Active strength 10 mg/1
Pharmacologic classes Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base OPSUMIT
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MACITENTAN 10 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii Z9K9Y9WMVL Rxcui 1442137, 1442143
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66215-501-15 OPSUMIT 1 in 1 CARTON TABLET, FILM COATED 1 35 66215-501-15 OPSUMIT 15 in 1 BLISTER PACK TABLET, FILM COATED 15 35 66215-501-30 OPSUMIT 1 in 1 CARTON TABLET, FILM COATED 1 35 66215-501-30 OPSUMIT 30 in 1 BOTTLE TABLET, FILM COATED 30 35
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded macitentan ACTIVE INGREDIENT Z9K9Y9WMVL OPSUMIT (MACITENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 7 macitentan ACTIVE MOIETY Z9K9Y9WMVL OPSUMIT (MACITENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 7 Cellulose, Microcrystalline INACTIVE INGREDIENT OP1R32D61U OPSUMIT (MACITENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 7 Lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X OPSUMIT (MACITENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 7 Magnesium stearate INACTIVE INGREDIENT 70097M6I30 OPSUMIT (MACITENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 7 Polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H OPSUMIT (MACITENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 7 Povidones INACTIVE INGREDIENT FZ989GH94E OPSUMIT (MACITENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 7 Sodium starch glycolate type A potato INACTIVE INGREDIENT 5856J3G2A2 OPSUMIT (MACITENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66215-501 OPSUMIT (MACITENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] 35 Current NDC, Legacy NDC, 4 package rows 20250412_1e484a50-55db-4b85-8c57-6cd1b0353abd.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 66215-501-15 66215050115 1 BLISTER PACK in 1 CARTON (66215-501-15) / 15 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2013-11-04 0000-00-00 No No Current 66215-501-30 66215050130 1 BOTTLE in 1 CARTON (66215-501-30) / 30 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2013-11-04 0000-00-00 No No Current