Orange Book product · Brand (NDA)
IMODIUM
LOPERAMIDE HYDROCHLORIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
LOPERAMIDE HYDROCHLORIDE
Strength
2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 017694
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2005LOPERAMIDE HYDROCHLORIDEBrand (NDA)
NDA 021855 · BIONPHARMA
- 1997IMODIUM A-D EZ CHEWSBrand (NDA)
NDA 020448 · J AND J CONSUMER INC
- 1989IMODIUM A-DBrand (NDA)
NDA 019860 · KENVUE BRANDS
- 1988IMODIUM A-DBrand (NDA)
NDA 019487 · KENVUE BRANDS
- 1984IMODIUMBrand (NDA)
NDA 019037 · JANSSEN PHARMS
- —IMODIUMBrand (NDA)
NDA 017690 · J AND J CONSUMER INC
- 2025LOPERAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 220372 · AUROBINDO PHARMA
- 2025LOPERAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 220153 · MARKSANS PHARMA
- 2025LOPERAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 220100 · BIONPHARMA
- 2023LOPERAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 218122 · AUROBINDO PHARMA LTD
- 2023LOPERAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 217840 · JUBILANT CADISTA
- 2023LOPERAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 217471 · ZYDUS LIFESCIENCES
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
