FDA.reportPublic FDA data

Ambrisentan

Product NDC
70771-1363
11-digit product format
707711363
Labeler code
70771
Product ID
70771-1363_14a85c38-61bf-4621-8e3a-34ab57a15758
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ambrisentan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA210058
Marketing category
ANDA
Marketing start
2019-04-12
Substance
AMBRISENTAN
Active strength
5 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
Ambrisentan
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMBRISENTAN5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHW6NV07QEC
Rxcui722116, 722122

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
d7db2b61-402f-f2c9-6e9c-10d81037d0baProduct name320230126

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1363-1Ambrisentan100 in 1 BOTTLETABLET, FILM COATED10010
70771-1363-3Ambrisentan30 in 1 BOTTLETABLET, FILM COATED3010
70771-1363-7Ambrisentan1 in 1 CARTONTABLET, FILM COATED110
70771-1363-7Ambrisentan10 in 1 BLISTER PACKTABLET, FILM COATED1010
70771-1363-8Ambrisentan3 in 1 CARTONTABLET, FILM COATED310
70771-1363-8Ambrisentan10 in 1 BLISTER PACKTABLET, FILM COATED1010
70771-1363-9Ambrisentan90 in 1 BOTTLETABLET, FILM COATED9010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1363AMBRISENTAN TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]10Current NDC, Legacy NDC, 7 package rows20241127_0e3e3320-27ac-404f-9f01-3d82696e768a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
722116ambrisentan 10 MG Oral TabletPSN0e3e3320-27ac-404f-9f01-3d82696e768a10
722122ambrisentan 5 MG Oral TabletPSN0e3e3320-27ac-404f-9f01-3d82696e768a10
722116ambrisentan 10 MG Oral TabletSCD0e3e3320-27ac-404f-9f01-3d82696e768a10
722122ambrisentan 5 MG Oral TabletSCD0e3e3320-27ac-404f-9f01-3d82696e768a10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1363-170771136301100 TABLET, FILM COATED in 1 BOTTLE (70771-1363-1) 2019-04-120000-00-00NoNoCurrent
70771-1363-37077113630330 TABLET, FILM COATED in 1 BOTTLE (70771-1363-3) 2019-04-120000-00-00NoNoCurrent
70771-1363-7707711363071 BLISTER PACK in 1 CARTON (70771-1363-7) / 10 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2019-04-120000-00-00NoNoCurrent
70771-1363-8707711363083 BLISTER PACK in 1 CARTON (70771-1363-8) / 10 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2019-04-120000-00-00NoNoCurrent
70771-1363-97077113630990 TABLET, FILM COATED in 1 BOTTLE (70771-1363-9) 2019-04-120000-00-00NoNoCurrent