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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 220372

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NDA 220372 describes LOPERAMIDE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma, Aurobindo Pharma Ltd, Bionpharma, Chartwell Rx, Edenbridge Pharms, Jubilant Cadista, Mylan, Onesource Specialty, Roxane, Rubicon Research, Teva, Zydus Lifesciences, Allied, Alpharma Us Pharms, Duramed Pharms Barr, Pai Holdings, Perrigo, Perrigo R And D, Watson Labs, Wockhardt Bio Ag, Able, Contract Pharmacal, L Perrigo Co, LNK, Marksans Pharma, Ohm Labs, Granules, Guardian Drug, Hetero Labs Ltd V, and Sun Pharm Inds Ltd, and is included in forty NDAs. It is available from one hundred and one suppliers. Additional details are available on the LOPERAMIDE HYDROCHLORIDE profile page.

The generic ingredient in LOPERAMIDE HYDROCHLORIDE is loperamide hydrochloride; simethicone. There are eleven drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the loperamide hydrochloride; simethicone profile page.

Summary for 220372

Tradename:	LOPERAMIDE HYDROCHLORIDE
Applicant:	Aurobindo Pharma
Ingredient:	loperamide hydrochloride
Patents:	0

Pharmacology for NDA: 220372

Mechanism of Action	Opioid Agonists

Medical Subject Heading (MeSH) Categories for 220372

Antidiarrheals

Suppliers and Packaging for NDA: 220372

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	CAPSULE;ORAL	220372	ANDA	Aurohealth LLC	58602-727	58602-727-74	1 BLISTER PACK in 1 CARTON (58602-727-74) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	CAPSULE;ORAL	220372	ANDA	Aurohealth LLC	58602-727	58602-727-75	2 BLISTER PACK in 1 CARTON (58602-727-75) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	CAPSULE;ORAL			Strength	2MG
Approval Date:	Dec 29, 2025	TE:		RLD:	No

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