FDA.reportPublic FDA data

Macitentan

Product NDC
42385-907
11-digit product format
423850907
Labeler code
42385
Product ID
42385-907_93f0ab4a-4756-4915-a000-ed65b26cd61c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Macitentan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Laurus Labs Limited
Application
ANDA211120
Marketing category
ANDA
Marketing start
2026-05-15
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211120-001MACITENTANMACITENTAN10MGTABLET / ORALAB2025-11-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A211120-001AB

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
A211120-001PC2026-12-03

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211120-001MACITENTAN10MGTABLET / ORALAB2025-11-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211120-001MACITENTAN10MGTABLET / ORALAB2025-11-0531067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211120-001MACITENTAN10MGTABLET / ORALAB2025-11-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211120-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211120-001AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211120-001AB1a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211120-001PC2026-12-03a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Macitentan
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MACITENTAN10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Z9K9Y9WMVLInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1442137Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
93f0ab4a-4756-4915-a000-ed65b26cd61cAvailable on FDA.report

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
42385-907-15Macitentan1 in 1 CARTONTABLET, FILM COATED11
42385-907-15Macitentan15 in 1 BLISTER PACKTABLET, FILM COATED151
42385-907-30Macitentan30 in 1 BOTTLETABLET, FILM COATED301

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MacitentanMACITENTANLaurus Labs Limited93f0ab4a-4756-4915-a000-ed65b26cd61c2025-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211120
application number: ANDA211120
ndc (product): 42385-907

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1442137macitentan 10 MG Oral TabletPSN93f0ab4a-4756-4915-a000-ed65b26cd61c1
1442137macitentan 10 MG Oral TabletSCD93f0ab4a-4756-4915-a000-ed65b26cd61c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42385-907-15423850907151 BLISTER PACK in 1 CARTON (42385-907-15) / 15 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2026-05-15NoNoCurrent
42385-907-304238509073030 TABLET, FILM COATED in 1 BOTTLE (42385-907-30) 2026-05-15NoNoCurrent