Ambrisentan

Product NDC
51407-595
11-digit product format
514070595
Labeler code
51407
Product ID
51407-595_496834ab-a472-147d-e063-6394a90a12f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMBRISENTAN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA210701
Marketing category
ANDA
Marketing start
2022-05-19
Substance
AMBRISENTAN
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

Additional Listing Data#

Finished product
Yes
Brand name base
Ambrisentan
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMBRISENTAN10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHW6NV07QEC
Rxcui722116, 722122

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
d7db2b61-402f-f2c9-6e9c-10d81037d0baProduct name320230126
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51407-595-30Ambrisentan30 in 1 BOTTLETABLET, FILM COATED303

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
722116ambrisentan 10 MG Oral TabletPSN4396bab5-2851-62ef-e063-6294a90af76e3
722122ambrisentan 5 MG Oral TabletPSN4396bab5-2851-62ef-e063-6294a90af76e3
722116ambrisentan 10 MG Oral TabletSCD4396bab5-2851-62ef-e063-6294a90af76e3
722122ambrisentan 5 MG Oral TabletSCD4396bab5-2851-62ef-e063-6294a90af76e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51407-595-305140705953030 TABLET, FILM COATED in 1 BOTTLE (51407-595-30) 2025-11-17NoNoCurrent