LOPERAMIDE HYDROCHLORIDE- loperamide hydrochloride capsule 
Zydus Lifesciences Limited

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Loperamide Hydrochloride Capsules, USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Loperamide hydrochloride capsules USP, 2 mg

NDC 70771-1769-1

100 capsules

Rx only

2 mg 100s count
LOPERAMIDE HYDROCHLORIDE 
loperamide hydrochloride capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1769
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE2 mg
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
POVIDONE K30 (UNII: U725QWY32X)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorYELLOW (cream opaque cap) , YELLOW (cream opaque body) Scoreno score
ShapeCAPSULESize16mm
FlavorImprint Code 1701
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1769-1100 in 1 BOTTLE; Type 0: Not a Combination Product06/25/2023
2NDC:70771-1769-5500 in 1 BOTTLE; Type 0: Not a Combination Product06/25/2023
3NDC:70771-1769-410 in 1 CARTON06/25/2023
3NDC:70771-1769-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21747106/25/2023
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1769) , MANUFACTURE(70771-1769)

Revised: 6/2023
Document Id: b43ff8ed-7175-4a7a-8e42-5c66324b495c
Set id: 5d13405c-8fd7-454f-9b49-3d8b9ef672b8
Version: 1
Effective Time: 20230619
 
Zydus Lifesciences Limited