LOPERAMIDE HYDROCHLORIDE capsule

Loperamide hydrochloride by

Drug Labeling and Warnings

Loperamide hydrochloride 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

Loperamide hydrochloride capsules USP, 2 mg

NDC: 70771-1769-1

100 capsules

Rx only

INGREDIENTS AND APPEARANCE

LOPERAMIDE HYDROCHLORIDE 
loperamide hydrochloride capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1769
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II)	LOPERAMIDE HYDROCHLORIDE	2 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	YELLOW (cream opaque cap) , YELLOW (cream opaque body)	Score	no score
Shape	CAPSULE	Size	16mm
Flavor		Imprint Code	1701
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1769-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/25/2023
2	NDC: 70771-1769-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	06/25/2023
3	NDC: 70771-1769-4	10 in 1 CARTON	06/25/2023
3	NDC: 70771-1769-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA217471	06/25/2023

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		863362789	ANALYSIS(70771-1769) , MANUFACTURE(70771-1769)