FDA.reportPublic FDA data

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
IngredientStrength
MACITENTAN10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZ9K9Y9WMVL
Rxcui1442137, 1442143

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
20ae0006-d78c-4dba-9e3e-6ae424841903Product name120250127
213da918-5ef0-42e4-b7f0-17d9bae8699aProduct name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66215-501-15OPSUMIT1 in 1 CARTONTABLET, FILM COATED135
66215-501-15OPSUMIT15 in 1 BLISTER PACKTABLET, FILM COATED1535
66215-501-30OPSUMIT1 in 1 CARTONTABLET, FILM COATED135
66215-501-30OPSUMIT30 in 1 BOTTLETABLET, FILM COATED3035

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66215-501OPSUMIT (MACITENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.]35Current NDC, Legacy NDC, 4 package rows20250412_1e484a50-55db-4b85-8c57-6cd1b0353abd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1442137macitentan 10 MG Oral TabletPSN1e484a50-55db-4b85-8c57-6cd1b0353abd35
1442143Opsumit 10 MG Oral TabletPSN1e484a50-55db-4b85-8c57-6cd1b0353abd35
1442143macitentan 10 MG Oral Tablet [Opsumit]SBD1e484a50-55db-4b85-8c57-6cd1b0353abd35
1442137macitentan 10 MG Oral TabletSCD1e484a50-55db-4b85-8c57-6cd1b0353abd35
1442143Opsumit 10 MG Oral TabletSY1e484a50-55db-4b85-8c57-6cd1b0353abd35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66215-501-15662150501151 BLISTER PACK in 1 CARTON (66215-501-15) / 15 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2013-11-040000-00-00NoNoCurrent
66215-501-30662150501301 BOTTLE in 1 CARTON (66215-501-30) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2013-11-040000-00-00NoNoCurrent