Last Updated: May 10, 2026

Details for New Drug Application (NDA): 220100

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NDA 220100 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 two 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 220100

Tradename:	LOPERAMIDE HYDROCHLORIDE
Applicant:	Bionpharma
Ingredient:	loperamide hydrochloride
Patents:	0

Pharmacology for NDA: 220100

Mechanism of Action	Opioid Agonists

Medical Subject Heading (MeSH) Categories for 220100

Antidiarrheals

Suppliers and Packaging for NDA: 220100

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	SOLUTION;ORAL	220100	ANDA	DOLGENCORP INC	55910-155	55910-155-55	120 mL in 1 BOTTLE (55910-155-55)
LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	SOLUTION;ORAL	220100	ANDA	Bionpharma Inc.	69452-405	69452-405-55	120 mL in 1 BOTTLE (69452-405-55)

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	SOLUTION;ORAL			Strength	1MG/7.5ML
Approval Date:	Sep 19, 2025	TE:		RLD:	No

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