LUBIPROSTONE - lubiprostone capsule 
Zydus Lifesciences Limited

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Lubiprostone Capsules

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1763-6

Lubiprostone Capsules, 8 mcg

60 Capsules

Rx only

8 mcg label

NDC 70771-1764-6

Lubiprostone Capsules, 24 mcg

60 Capsules

Rx only

24 mcg label
LUBIPROSTONE 
lubiprostone capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1763
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LUBIPROSTONE (UNII: 7662KG2R6K) (LUBIPROSTONE - UNII:7662KG2R6K) LUBIPROSTONE8 ug
Inactive Ingredients
Ingredient NameStrength
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
ColorPINK (light pink to pink colored) Scoreno score
ShapeOVALSize9mm
FlavorImprint Code 8
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1763-660 in 1 BOTTLE; Type 0: Not a Combination Product03/23/2023
2NDC:70771-1763-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/23/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21413103/23/2023
LUBIPROSTONE 
lubiprostone capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1764
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LUBIPROSTONE (UNII: 7662KG2R6K) (LUBIPROSTONE - UNII:7662KG2R6K) LUBIPROSTONE24 ug
Inactive Ingredients
Ingredient NameStrength
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
ColorYELLOW (light yellow colored) Scoreno score
ShapeOVALSize9mm
FlavorImprint Code 24
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1764-660 in 1 BOTTLE; Type 0: Not a Combination Product03/23/2023
2NDC:70771-1764-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/23/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21413103/23/2023
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1763, 70771-1764) , MANUFACTURE(70771-1763, 70771-1764)

Revised: 3/2023
Document Id: d529a527-d19e-4cec-a117-ddc6cab4a8b1
Set id: 81f9c9de-f89d-4ab0-a8ca-18d3691e42f9
Version: 1
Effective Time: 20230324
 
Zydus Lifesciences Limited