NDC 70710-1179

Ambrisentan

Ambrisentan

Ambrisentan is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Ambrisentan.

Product ID70710-1179_18d85ac0-9b44-49a9-8a8b-81005dc7977d
NDC70710-1179
Product TypeHuman Prescription Drug
Proprietary NameAmbrisentan
Generic NameAmbrisentan
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-04-12
Marketing CategoryANDA / ANDA
Application NumberANDA210058
Labeler NameZydus Pharmaceuticals (USA) Inc.
Substance NameAMBRISENTAN
Active Ingredient Strength5 mg/1
Pharm ClassesEndothelin Receptor Antagonist [EPC],Endothelin Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 70710-1179-1

100 TABLET, FILM COATED in 1 BOTTLE (70710-1179-1)
Marketing Start Date2019-04-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70710-1179-1 [70710117901]

Ambrisentan TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210058
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-12

NDC 70710-1179-8 [70710117908]

Ambrisentan TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210058
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-12

NDC 70710-1179-7 [70710117907]

Ambrisentan TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210058
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-12

NDC 70710-1179-3 [70710117903]

Ambrisentan TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210058
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-12

NDC 70710-1179-9 [70710117909]

Ambrisentan TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210058
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-12

Drug Details

Active Ingredients

IngredientStrength
AMBRISENTAN5 mg/1

OpenFDA Data

SPL SET ID:37af3191-0ed3-4783-8747-065f1462f2d2
Manufacturer
UNII

Pharmacological Class

  • Endothelin Receptor Antagonist [EPC]
  • Endothelin Receptor Antagonists [MoA]

NDC Crossover Matching brand name "Ambrisentan" or generic name "Ambrisentan"

NDCBrand NameGeneric Name
0378-4270Ambrisentanambrisentan
0378-4271Ambrisentanambrisentan
0591-2405AmbrisentanAmbrisentan
0591-2406AmbrisentanAmbrisentan
42291-018AMBRISENTANAMBRISENTAN
42291-019AMBRISENTANAMBRISENTAN
42794-051AMBRISENTANAMBRISENTAN
42794-052AMBRISENTANAMBRISENTAN
47335-236ambrisentanambrisentan
47335-237ambrisentanambrisentan
49884-353AmbrisentanAmbrisentan
49884-354AmbrisentanAmbrisentan
59651-494ambrisentanambrisentan
59651-495ambrisentanambrisentan
60505-4552AmbrisentanAMBRISENTAN
60505-4553AmbrisentanAMBRISENTAN
69097-386AmbrisentanAmbrisentan
69097-387AmbrisentanAmbrisentan
70710-1179AmbrisentanAmbrisentan
70710-1180AmbrisentanAmbrisentan
70771-1363AmbrisentanAmbrisentan
70771-1364AmbrisentanAmbrisentan
76282-684AmbrisentanAmbrisentan
76282-685AmbrisentanAmbrisentan
61958-0801LetairisAMBRISENTAN
61958-0802LetairisAMBRISENTAN

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.