FDA.reportPublic FDA data

AMBRISENTAN

Product NDC
42794-051
11-digit product format
427940051
Labeler code
42794
Product ID
42794-051_f1f20771-a78f-74cf-e053-2995a90a6adf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMBRISENTAN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sigmapharm Laboratories, LLC
Application
ANDA208354
Marketing category
ANDA
Marketing start
2019-04-10
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
42794-051-08AMBRISENTAN30 in 1 BOTTLE, PLASTICTABLET, FILM COATED307
42794-051-22AMBRISENTAN10 in 1 BOTTLE, PLASTICTABLET, FILM COATED107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42794-051-08EA - Each42794-05158e36980-6e2c-4128-927b-bd06663f69a212019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42794-051AMBRISENTAN TABLET, FILM COATED [SIGMAPHARM LABORATORIES, LLC]7Current NDC, Legacy NDC, 2 package rows20230111_e20ab2fe-bc9f-48a3-b15a-e4bc9532c2ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
722116ambrisentan 10 MG Oral TabletPSNe20ab2fe-bc9f-48a3-b15a-e4bc9532c2ac7
722122ambrisentan 5 MG Oral TabletPSNe20ab2fe-bc9f-48a3-b15a-e4bc9532c2ac7
722116ambrisentan 10 MG Oral TabletSCDe20ab2fe-bc9f-48a3-b15a-e4bc9532c2ac7
722122ambrisentan 5 MG Oral TabletSCDe20ab2fe-bc9f-48a3-b15a-e4bc9532c2ac7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42794-051-084279400510830 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42794-051-08) 2019-04-100000-00-00NoNoCurrent
42794-051-224279400512210 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42794-051-22) 2019-04-100000-00-00NoNoCurrent