You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 26, 2026

Details for New Drug Application (NDA): 217471

✉ Email this page to a colleague

« Back to Dashboard

NDA 217471 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 217471

Tradename:	LOPERAMIDE HYDROCHLORIDE
Applicant:	Zydus Lifesciences
Ingredient:	loperamide hydrochloride
Patents:	0

Pharmacology for NDA: 217471

Mechanism of Action	Opioid Agonists

Medical Subject Heading (MeSH) Categories for 217471

Antidiarrheals

Suppliers and Packaging for NDA: 217471

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	CAPSULE;ORAL	217471	ANDA	Zydus Lifesciences Limited	70771-1769	70771-1769-1	100 CAPSULE in 1 BOTTLE (70771-1769-1)
LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	CAPSULE;ORAL	217471	ANDA	Zydus Lifesciences Limited	70771-1769	70771-1769-4	10 BLISTER PACK in 1 CARTON (70771-1769-4) / 10 CAPSULE in 1 BLISTER PACK (70771-1769-2)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	2MG
Approval Date:	Mar 23, 2023	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.