Bosentan Tablets

SPL v6

SPL

SPL Set ID 02892f47-0d59-4254-9ee7-d524278fdd79

Route

ORAL

Published

Effective Date 2023-09-20

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Bosentan Anhydrous (62.5 mg)

Inactive Ingredients

Ethylcellulose, Unspecified Ferric Oxide Red Ferric Oxide Yellow Glyceryl Dibehenate Hypromellose, Unspecified Magnesium Stearate Povidone Sodium Starch Glycolate Type A Potato Starch, Corn Talc Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance

Imprint: 447 Shape: round Shape: oval Color: pink Size: 7 mm Size: 11 mm Score: 1

Marketing Status

ANDA Active Since 2019-05-01

Description

NDC 70771-1017-6 Bosentan tablets, 62.5 mg 60 tablets Rx only NDC 70771-1018-6 Bosentan tablets, 125 mg 60 tablets Rx only

Medication Information

Description

NDC 70771-1017-6 Bosentan tablets, 62.5 mg 60 tablets Rx only NDC 70771-1018-6 Bosentan tablets, 125 mg 60 tablets Rx only

Package Label.principal Display Panel

NDC 70771-1017-6

Bosentan tablets, 62.5 mg

60 tablets

Rx only

NDC 70771-1018-6

Bosentan tablets, 125 mg

60 tablets

Rx only

Structured Label Content

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

NDC 70771-1017-6

Bosentan tablets, 62.5 mg

60 tablets

Rx only

NDC 70771-1018-6

Bosentan tablets, 125 mg

60 tablets

Rx only

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 70771-1017-6 Bosentan tablets, 62.5 mg 60 tablets Rx only NDC 70771-1018-6 Bosentan tablets, 125 mg 60 tablets Rx only"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:43:57.578567 · Updated: 2026-03-14T22:18:11.806691