Lubiprostone (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0480-3479-06

Lubiprostone Capsules 8 mcg

Swallow Whole – Do NOT Break Apart or Chew.

Rx only60 Capsules

new
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0480-4138-06

Lubiprostone Capsules 24 mcg

Swallow Whole – Do NOT Break Apart or Chew.

Rx only60 Capsules

new
(click image for full-size original)
LUBIPROSTONE lubiprostone capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0480-3479
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LUBIPROSTONE (LUBIPROSTONE) LUBIPROSTONE 8 ug
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
GELATIN, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
LECITHIN, SOYBEAN
MEDIUM-CHAIN TRIGLYCERIDES
PROPYLENE GLYCOL
WATER
SORBITOL SOLUTION
TITANIUM DIOXIDE
Product Characteristics
Color pink (opaque pink) Score no score
Shape OVAL Size 9mm
Flavor Imprint Code A08
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0480-3479-06 60 CAPSULE, GELATIN COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209920 01/03/2023
LUBIPROSTONE lubiprostone capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0480-4138
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LUBIPROSTONE (LUBIPROSTONE) LUBIPROSTONE 24 ug
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE
D&C YELLOW NO. 10
FD&C RED NO. 40
GELATIN, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
LECITHIN, SOYBEAN
MEDIUM-CHAIN TRIGLYCERIDES
PROPYLENE GLYCOL
WATER
SORBITOL SOLUTION
Product Characteristics
Color orange (clear orange) Score no score
Shape OVAL Size 9mm
Flavor Imprint Code A04
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0480-4138-06 60 CAPSULE, GELATIN COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209920 01/03/2023
Labeler — Teva Pharmaceuticals, Inc. (022629579)

Revised: 05/2022 Teva Pharmaceuticals, Inc.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.