FDA.reportPublic FDA data

Macitentan

Product NDC
62332-373
Requested package NDC
62332-373-30
11-digit product format
623320373
Labeler code
62332
Product ID
62332-373_474cbf43-5f14-4bbb-b3c9-0cbc575fd506
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Macitentan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA211128
Marketing category
ANDA
Marketing start
2026-06-06
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211128-001MACITENTANMACITENTAN10MGTABLET / ORALAB2025-08-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211128-001AB

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
2026-09-14 22:38:342026-08A211128-001MACITENTAN10MGTABLET / ORALAB2025-08-1884e616aacf4f…
2026-08-18 06:07:402026-07A211128-001MACITENTAN10MGTABLET / ORALAB2025-08-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211128-001MACITENTAN10MGTABLET / ORALAB2025-08-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211128-001MACITENTAN10MGTABLET / ORALAB2025-08-1831067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211128-001MACITENTAN10MGTABLET / ORALAB2025-08-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A211128-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A211128-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211128-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211128-001AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211128-001AB1a50c72e98297…

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
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
98b3309a-5012-42b5-b773-a38c2f52296cAvailable on FDA.report

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MacitentanMACITENTANAlembic Pharmaceuticals Limited4d9d9a84-6853-4004-b20a-8849b34453a42026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211128
application number: ANDA211128
MacitentanMACITENTANAlembic Pharmaceuticals Inc.98b3309a-5012-42b5-b773-a38c2f52296c2026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211128
application number: ANDA211128
ndc (package): 62332-373-30
ndc (product): 62332-373
ndc11 (package): 62332037330

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62332-373-306233203733030 TABLET, FILM COATED in 1 BOTTLE (62332-373-30) 2026-06-06NoNoCurrent