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FDA Drug information

Lubiprostone

Read time: 1 mins
Marketing start date: 23 Dec 2024
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Summary of product characteristics


Effective Time

20230324

Version

1

Spl Product Data Elements

Lubiprostone Lubiprostone LUBIPROSTONE LUBIPROSTONE 1,4-SORBITAN FERRIC OXIDE RED FERROSOFERRIC OXIDE GELATIN, UNSPECIFIED MEDIUM-CHAIN TRIGLYCERIDES PROPYLENE GLYCOL SHELLAC SORBITOL TITANIUM DIOXIDE WATER light pink to pink colored 8 Lubiprostone Lubiprostone LUBIPROSTONE LUBIPROSTONE 1,4-SORBITAN FERROSOFERRIC OXIDE GELATIN, UNSPECIFIED MEDIUM-CHAIN TRIGLYCERIDES PROPYLENE GLYCOL SHELLAC SORBITOL WATER light yellow colored 24

Application Number

ANDA214131

Brand Name

Lubiprostone

Generic Name

Lubiprostone

Product Ndc

70771-1764

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1763-6 Lubiprostone Capsules, 8 mcg 60 Capsules Rx only NDC 70771-1764-6 Lubiprostone Capsules, 24 mcg 60 Capsules Rx only 8 mcg label 24 mcg label

Drug section

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