Lubiprostone by Zydus Lifesciences Limited LUBIPROSTONE capsule

Lubiprostone by

Drug Labeling and Warnings

Lubiprostone by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

LUBIPROSTONE 
lubiprostone capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1763
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LUBIPROSTONE (UNII: 7662KG2R6K) (LUBIPROSTONE - UNII:7662KG2R6K)	LUBIPROSTONE	8 ug

Inactive Ingredients
Ingredient Name	Strength
1,4-SORBITAN (UNII: AV0YTZ4E6J)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	PINK (light pink to pink colored)	Score	no score
Shape	OVAL	Size	9mm
Flavor		Imprint Code	8
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1763-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	03/23/2023
2	NDC: 70771-1763-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/23/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA214131	03/23/2023

LUBIPROSTONE 
lubiprostone capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1764
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LUBIPROSTONE (UNII: 7662KG2R6K) (LUBIPROSTONE - UNII:7662KG2R6K)	LUBIPROSTONE	24 ug

Inactive Ingredients
Ingredient Name	Strength
1,4-SORBITAN (UNII: AV0YTZ4E6J)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	YELLOW (light yellow colored)	Score	no score
Shape	OVAL	Size	9mm
Flavor		Imprint Code	24
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1764-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	03/23/2023
2	NDC: 70771-1764-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/23/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA214131	03/23/2023

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		918596198	ANALYSIS(70771-1763, 70771-1764) , MANUFACTURE(70771-1763, 70771-1764)