NDC 69097-386

Ambrisentan

Ambrisentan

Ambrisentan is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Cipla Usa Inc.. The primary component is Ambrisentan.

Product ID69097-386_0c6a8398-6d21-40fd-a789-e7b22966f1a2
NDC69097-386
Product TypeHuman Prescription Drug
Proprietary NameAmbrisentan
Generic NameAmbrisentan
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-04-26
Marketing CategoryANDA / ANDA
Application NumberANDA210715
Labeler NameCipla USA Inc.
Substance NameAMBRISENTAN
Active Ingredient Strength5 mg/1
Pharm ClassesEndothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 69097-386-02

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69097-386-02)
Marketing Start Date2019-04-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69097-386-19 [69097038619]

Ambrisentan TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210715
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-26

NDC 69097-386-02 [69097038602]

Ambrisentan TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210715
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-26

Drug Details

Active Ingredients

IngredientStrength
AMBRISENTAN5 mg/1

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

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