FDA.reportPublic FDA data

ambrisentan

Product NDC
47335-236
11-digit product format
473350236
Labeler code
47335
Product ID
47335-236_294580cb-5622-4f48-89a8-99000a7a2964
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ambrisentan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA210784
Marketing category
ANDA
Marketing start
2019-04-29
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
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
47335-236-60ambrisentan10 in 1 BLISTER PACKTABLET, FILM COATED109
47335-236-64ambrisentan3 in 1 CARTONTABLET, FILM COATED39
47335-236-66ambrisentan1 in 1 CARTONTABLET, FILM COATED19
47335-236-83ambrisentan30 in 1 BOTTLETABLET, FILM COATED309
47335-236-85ambrisentan10 in 1 BOTTLETABLET, FILM COATED109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-236-83EA - Each47335-23662d0577e-c1fb-4de8-8db2-4959d1811f6012019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-236AMBRISENTAN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]9Current NDC, Legacy NDC, 5 package rows20250509_a4978a54-1799-43d6-85dd-05fa9de0a5d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
722116ambrisentan 10 MG Oral TabletPSNa4978a54-1799-43d6-85dd-05fa9de0a5d79
722122ambrisentan 5 MG Oral TabletPSNa4978a54-1799-43d6-85dd-05fa9de0a5d79
722116ambrisentan 10 MG Oral TabletSCDa4978a54-1799-43d6-85dd-05fa9de0a5d79
722122ambrisentan 5 MG Oral TabletSCDa4978a54-1799-43d6-85dd-05fa9de0a5d79

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47335-236-604733502366010 in 1 BLISTER PACKHistorical
47335-236-64473350236643 BLISTER PACK in 1 CARTON (47335-236-64) / 10 TABLET, FILM COATED in 1 BLISTER PACK (47335-236-60) 3 blister pack2019-04-290000-00-00NoNoCurrent
47335-236-66473350236661 BLISTER PACK in 1 CARTON (47335-236-66) / 10 TABLET, FILM COATED in 1 BLISTER PACK (47335-236-60) 1 blister pack2019-04-290000-00-00NoNoCurrent
47335-236-834733502368330 TABLET, FILM COATED in 1 BOTTLE (47335-236-83) 2019-04-290000-00-00NoNoCurrent
47335-236-854733502368510 TABLET, FILM COATED in 1 BOTTLE (47335-236-85) 2019-04-290000-00-00NoNoCurrent