Ambrisentan Tablets

SPL v10

SPL

SPL Set ID 0e3e3320-27ac-404f-9f01-3d82696e768a

Route

ORAL

Published

Effective Date 2023-10-19

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Ambrisentan (5 mg)

Inactive Ingredients

Croscarmellose Sodium Lactose Monohydrate Lecithin, Soybean Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Povidone Talc Titanium Dioxide Fd&c Red No. 40 Aluminum Oxide Polyvinyl Alcohol, Unspecified

Identifiers & Packaging

Pill Appearance

Imprint: 1180 Shape: round Shape: oval Color: pink Color: white Size: 8 mm Size: 10 mm Score: 1

Marketing Status

ANDA Active Since 2019-04-12

Description

NDC 70771-1363-3 Ambrisentan Tablets, 5 mg 30 Tablets Rx only NDC 70771-1364-3 Ambrisentan Tablets, 10 mg 30 Tablets Rx only

Medication Information

Description

NDC 70771-1363-3 Ambrisentan Tablets, 5 mg 30 Tablets Rx only NDC 70771-1364-3 Ambrisentan Tablets, 10 mg 30 Tablets Rx only

Package Label.principal Display Panel

NDC 70771-1363-3

Ambrisentan Tablets, 5 mg

30 Tablets

Rx only

NDC 70771-1364-3

Ambrisentan Tablets, 10 mg

30 Tablets

Rx only

Structured Label Content

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC 70771-1363-3

Ambrisentan Tablets, 5 mg

30 Tablets

Rx only

NDC 70771-1364-3

Ambrisentan Tablets, 10 mg

30 Tablets

Rx only

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 70771-1363-3 Ambrisentan Tablets, 5 mg 30 Tablets Rx only NDC 70771-1364-3 Ambrisentan Tablets, 10 mg 30 Tablets Rx only"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:43:55.980528 · Updated: 2026-03-14T22:18:11.806691