NDC 69097-387

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 ID: 69097-387_0c6a8398-6d21-40fd-a789-e7b22966f1a2
• NDC: 69097-387
• Product Type: Human Prescription Drug
• Proprietary Name: Ambrisentan
• Generic Name: Ambrisentan
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-04-26
• Marketing Category: ANDA / ANDA
• Application Number: ANDA210715
• Labeler Name: Cipla USA Inc.
• Substance Name: AMBRISENTAN
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 69097-387-02

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69097-387-02)

• Marketing Start Date: 2019-04-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69097-387-02 [69097038702]

Ambrisentan TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA210715
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-04-26

NDC 69097-387-19 [69097038719]

Ambrisentan TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA210715
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-04-26

Drug Details

Active Ingredients

Ingredient	Strength
AMBRISENTAN	10 mg/1

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