FDA.reportPublic FDA data

Ambrisentan

Product NDC
60505-4553
11-digit product format
605054553
Labeler code
60505
Product ID
60505-4553_9ea6cb4f-0099-f884-4d51-8335310bf1b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMBRISENTAN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA210701
Marketing category
ANDA
Marketing start
2022-09-19
Substance
AMBRISENTAN
Active strength
10 mg/1
Pharmacologic classes
Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
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
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
60505-4553-0Ambrisentan10 in 1 BLISTER PACKTABLET, FILM COATED109
60505-4553-0Ambrisentan1 in 1 CARTONTABLET, FILM COATED19
60505-4553-1Ambrisentan10 in 1 BLISTER PACKTABLET, FILM COATED109
60505-4553-1Ambrisentan3 in 1 CARTONTABLET, FILM COATED39
60505-4553-3Ambrisentan30 in 1 BOTTLETABLET, FILM COATED309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-4553-3EA - Each60505-4553cf802aea-1c51-4f10-b4da-4a29901998c612022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-4553AMBRISENTAN TABLET, FILM COATED [APOTEX CORP.]6Current NDC, Legacy NDC, 5 package rows20250501_291a782a-77e1-8a8e-e1c8-2626f305c2b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
722116ambrisentan 10 MG Oral TabletPSN291a782a-77e1-8a8e-e1c8-2626f305c2b79
722122ambrisentan 5 MG Oral TabletPSN291a782a-77e1-8a8e-e1c8-2626f305c2b79
722116ambrisentan 10 MG Oral TabletSCD291a782a-77e1-8a8e-e1c8-2626f305c2b79
722122ambrisentan 5 MG Oral TabletSCD291a782a-77e1-8a8e-e1c8-2626f305c2b79
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 startMarketing endSampleExclude flagStatus
60505-4553-06050545530010 in 1 BLISTER PACKHistorical
60505-4553-16050545530110 in 1 BLISTER PACKHistorical
60505-4553-36050545530330 TABLET, FILM COATED in 1 BOTTLE (60505-4553-3) 2022-09-190000-00-00NoNoCurrent