NDC 42794-051

AMBRISENTAN

Ambrisentan

AMBRISENTAN is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Sigmapharm Laboratories, Llc. The primary component is Ambrisentan.

• Product ID: 42794-051_8698ad91-c3e4-e991-e053-2a91aa0ab762
• NDC: 42794-051
• Product Type: Human Prescription Drug
• Proprietary Name: AMBRISENTAN
• Generic Name: Ambrisentan
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-04-10
• Marketing Category: ANDA / ANDA
• Application Number: ANDA208354
• Labeler Name: Sigmapharm Laboratories, LLC
• Substance Name: AMBRISENTAN
• Active Ingredient Strength: 5 mg/1
• Pharm Classes: Endothelin Receptor Antagonist [EPC],Endothelin Receptor Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 42794-051-08

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42794-051-08)

• Marketing Start Date: 2019-04-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 42794-051-22 [42794005122]

AMBRISENTAN TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA208354
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-04-10

NDC 42794-051-08 [42794005108]

AMBRISENTAN TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA208354
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-04-10

Drug Details

Active Ingredients

Ingredient	Strength
AMBRISENTAN	5 mg/1

OpenFDA Data

• SPL SET ID: e20ab2fe-bc9f-48a3-b15a-e4bc9532c2ac
• Manufacturer:
  • Sigmapharm Laboratories, LLC
• UNII:
  • HW6NV07QEC
• UPC Code:
  • 0342794051081
  • 0342794052088

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0378-4270	Ambrisentan	ambrisentan
0378-4271	Ambrisentan	ambrisentan
0591-2405	Ambrisentan	Ambrisentan
0591-2406	Ambrisentan	Ambrisentan
42291-018	AMBRISENTAN	AMBRISENTAN
42291-019	AMBRISENTAN	AMBRISENTAN
42794-051	AMBRISENTAN	AMBRISENTAN
42794-052	AMBRISENTAN	AMBRISENTAN
47335-236	ambrisentan	ambrisentan
47335-237	ambrisentan	ambrisentan
49884-353	Ambrisentan	Ambrisentan
49884-354	Ambrisentan	Ambrisentan
59651-494	ambrisentan	ambrisentan
59651-495	ambrisentan	ambrisentan
60505-4552	Ambrisentan	AMBRISENTAN
60505-4553	Ambrisentan	AMBRISENTAN
69097-386	Ambrisentan	Ambrisentan
69097-387	Ambrisentan	Ambrisentan
70710-1179	Ambrisentan	Ambrisentan
70710-1180	Ambrisentan	Ambrisentan
70771-1363	Ambrisentan	Ambrisentan
70771-1364	Ambrisentan	Ambrisentan
76282-684	Ambrisentan	Ambrisentan
76282-685	Ambrisentan	Ambrisentan
61958-0801	Letairis	AMBRISENTAN
61958-0802	Letairis	AMBRISENTAN