NDC 0378-4270

Ambrisentan

Ambrisentan

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

• Product ID: 0378-4270_3ea35030-c5e4-4f6a-a83a-9fb41e436a9d
• NDC: 0378-4270
• Product Type: Human Prescription Drug
• Proprietary Name: Ambrisentan
• Generic Name: Ambrisentan
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-03-28
• Marketing Category: ANDA / ANDA
• Application Number: ANDA208441
• Labeler Name: Mylan Pharmaceuticals Inc.
• 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 0378-4270-93

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4270-93)

• Marketing Start Date: 2019-04-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-4270-32 [00378427032]

Ambrisentan TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA208441
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-04-29
• Marketing End Date: 2019-10-03

NDC 0378-4270-93 [00378427093]

Ambrisentan TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA208441
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-04-29

Drug Details

Active Ingredients

Ingredient	Strength
AMBRISENTAN	5 mg/1

OpenFDA Data

• SPL SET ID: 8080b009-361b-4505-b09a-0d91a0e4a2c0
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • HW6NV07QEC
• RxNorm Concept Unique ID - RxCUI:
  • 722122
  • 722116
• UPC Code:
  • 0303784271971
  • 0303784270974

Pharmacological Class

• 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