NDC 47335-237

ambrisentan

Ambrisentan

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

Product ID47335-237_180a5fe5-e14b-4a5a-8363-321bb51ccfaa
NDC47335-237
Product TypeHuman Prescription Drug
Proprietary Nameambrisentan
Generic NameAmbrisentan
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-04-29
Marketing CategoryANDA / ANDA
Application NumberANDA210784
Labeler NameSun Pharmaceutical Industries, Inc.
Substance NameAMBRISENTAN
Active Ingredient Strength10 mg/1
Pharm ClassesEndothelin Receptor Antagonist [EPC],Endothelin Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 47335-237-64

3 BLISTER PACK in 1 CARTON (47335-237-64) > 10 TABLET, FILM COATED in 1 BLISTER PACK (47335-237-60)
Marketing Start Date2019-04-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 47335-237-64 [47335023764]

ambrisentan TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210784
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-29

NDC 47335-237-60 [47335023760]

ambrisentan TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210784
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-29

NDC 47335-237-66 [47335023766]

ambrisentan TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210784
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-29

NDC 47335-237-83 [47335023783]

ambrisentan TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210784
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-29

Drug Details

Active Ingredients

IngredientStrength
AMBRISENTAN10 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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