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

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