FDA.reportPublic FDA data

Bosentan

Product NDC
70771-1018
11-digit product format
707711018
Labeler code
70771
Product ID
70771-1018_33935d05-c8ff-4d9e-91bf-fac9072d25fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bosentan
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA207760
Marketing category
ANDA
Marketing start
2019-05-01
Substance
BOSENTAN
Active strength
125 mg/1
Pharmacologic classes
Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207760-001BOSENTANBOSENTAN62.5MGTABLET / ORALAB2019-04-26
A207760-002BOSENTANBOSENTAN125MGTABLET / ORALAB2019-04-26

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
A207760-001AB
A207760-002AB

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BosentanBOSENTANZydus Lifesciences Limited02892f47-0d59-4254-9ee7-d524278fdd792024-11-25Exact identifier

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BOSENTAN125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ326023R30
Rxcui349253, 656659

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d212b88c-a939-e294-be87-fb95301c9fbbProduct name620251118
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1018-1Bosentan100 in 1 BOTTLETABLET1006
70771-1018-2Bosentan10 in 1 BLISTER PACKTABLET106
70771-1018-4Bosentan10 in 1 CARTONTABLET106
70771-1018-5Bosentan500 in 1 BOTTLETABLET5006
70771-1018-6Bosentan60 in 1 BOTTLETABLET606
70771-1018-8Bosentan180 in 1 BOTTLETABLET1806

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1018BOSENTAN TABLET [ZYDUS LIFESCIENCES LIMITED]6Current NDC, Legacy NDC, 6 package rows20241128_02892f47-0d59-4254-9ee7-d524278fdd79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
656659bosentan 125 MG Oral TabletPSN02892f47-0d59-4254-9ee7-d524278fdd796
349253bosentan 62.5 MG Oral TabletPSN02892f47-0d59-4254-9ee7-d524278fdd796
656659bosentan 125 MG Oral TabletSCD02892f47-0d59-4254-9ee7-d524278fdd796
349253bosentan 62.5 MG Oral TabletSCD02892f47-0d59-4254-9ee7-d524278fdd796
656659bosentan (as bosentan hydrochloride) 125 MG Oral TabletSY02892f47-0d59-4254-9ee7-d524278fdd796
349253bosentan (as bosentan hydrochloride) 62.5 MG Oral TabletSY02892f47-0d59-4254-9ee7-d524278fdd796

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1018-170771101801100 TABLET in 1 BOTTLE (70771-1018-1) 100 tablet2019-05-010000-00-00NoNoCurrent
70771-1018-27077110180210 in 1 BLISTER PACKHistorical
70771-1018-47077110180410 BLISTER PACK in 1 CARTON (70771-1018-4) / 10 TABLET in 1 BLISTER PACK (70771-1018-2) 10 blister pack2019-05-010000-00-00NoNoCurrent
70771-1018-570771101805500 TABLET in 1 BOTTLE (70771-1018-5) 500 tablet2019-05-010000-00-00NoNoCurrent
70771-1018-67077110180660 TABLET in 1 BOTTLE (70771-1018-6) 60 tablet2019-05-010000-00-00NoNoCurrent
70771-1018-870771101808180 TABLET in 1 BOTTLE (70771-1018-8) 180 tablet2019-05-010000-00-00NoNoCurrent