FDA Orange Book · active-ingredient family
Loperamide hydrochloride
Loperamide hydrochloride is approved as 7 brand and 31 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LOPERAMIDE HYDROCHLORIDE · NDA 021855
7
Brand (NDA)
31
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, solution, tablet, tablet, chewable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LOPERAMIDE HYDROCHLORIDERLD×2 | BIONPHARMA | NDA 021855 | — | Aug 04, 2005 | |
| IMODIUM A-D EZ CHEWSRLD | J AND J CONSUMER INC | NDA 020448 | — | Jul 24, 1997 | |
| IMODIUM A-DRLD | KENVUE BRANDS | NDA 019860 | — | Nov 22, 1989 | |
| IMODIUM A-DRLD×2 | KENVUE BRANDS | NDA 019487 | — | Mar 01, 1988 | |
| IMODIUMRLD | J AND J CONSUMER INC | NDA 017694 | — | Approved Prior to Jan 1, 1982 | |
| IMODIUM | JANSSEN PHARMS | NDA 019037 | — | Jul 31, 1984 | |
| IMODIUM | J AND J CONSUMER INC | NDA 017690 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (31)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LOPERAMIDE HYDROCHLORIDE | AUROBINDO PHARMA | ANDA 220372 | — | Dec 29, 2025 | |
| LOPERAMIDE HYDROCHLORIDE | MARKSANS PHARMA | ANDA 220153 | — | Nov 17, 2025 | |
| LOPERAMIDE HYDROCHLORIDE | BIONPHARMA | ANDA 220100 | — | Sep 19, 2025 | |
| LOPERAMIDE HYDROCHLORIDE | AUROBINDO PHARMA LTD | ANDA 218122 | AB | Sep 05, 2023 | |
| LOPERAMIDE HYDROCHLORIDE | JUBILANT CADISTA | ANDA 217840 | AB | Jul 05, 2023 | |
| LOPERAMIDE HYDROCHLORIDE | ZYDUS LIFESCIENCES | ANDA 217471 | AB | Mar 23, 2023 | |
| LOPERAMIDE HYDROCHLORIDE | RUBICON RESEARCH | ANDA 216876 | AB | Jan 26, 2023 | |
| LOPERAMIDE HYDROCHLORIDE | BIONPHARMA | ANDA 215579 | AB | Oct 22, 2021 | |
| LOPERAMIDE HYDROCHLORIDE | EDENBRIDGE PHARMS | ANDA 215001 | AB | Oct 06, 2021 | |
| LOPERAMIDE HYDROCHLORIDE | ONESOURCE SPECIALTY | ANDA 213070 | — | Aug 11, 2021 | |
| LOPERAMIDE HYDROCHLORIDE | AUROBINDO PHARMA | ANDA 206548 | — | Dec 15, 2015 | |
| LOPERAMIDE HYDROCHLORIDE | PERRIGO R AND D | ANDA 091292 | — | May 20, 2011 | |
| LOPERAMIDE HYDROCHLORIDE | LNK | ANDA 076497 | — | Jun 10, 2003 | |
| LOPERAMIDE HYDROCHLORIDE | L PERRIGO CO | ANDA 075232 | — | Jan 06, 2000 | |
| LOPERAMIDE HYDROCHLORIDE | DURAMED PHARMS BARR | ANDA 074991 | — | Dec 29, 1997 | |
| LOPERAMIDE HYDROCHLORIDE | WOCKHARDT BIO AG | ANDA 074730 | — | Aug 28, 1997 | |
| LOPERAMIDE HYDROCHLORIDE | PAI HOLDINGS | ANDA 074352 | — | Nov 17, 1995 | |
| LOPERAMIDE HYDROCHLORIDE | TEVA | ANDA 073478 | — | Jun 23, 1995 | |
| LOPERAMIDE HYDROCHLORIDE | ABLE | ANDA 073528 | — | Nov 30, 1993 | |
| LOPERAMIDE HYDROCHLORIDE | CONTRACT PHARMACAL | ANDA 073254 | — | Jul 30, 1993 | |
| LOPERAMIDE HYDROCHLORIDE | WATSON LABS | ANDA 073062 | — | May 28, 1993 | |
| LOPERAMIDE HYDROCHLORIDE | OHM LABS | ANDA 074091 | — | Dec 10, 1992 | |
| LOPERAMIDE HYDROCHLORIDE | PERRIGO | ANDA 074194 | — | Oct 30, 1992 | |
| LOPERAMIDE HYDROCHLORIDE | ALPHARMA US PHARMS | ANDA 073187 | — | Sep 15, 1992 | |
| LOPERAMIDE HYDROCHLORIDE | CHARTWELL RX | ANDA 072993 | — | Aug 28, 1992 | |
| LOPERAMIDE HYDROCHLORIDE | TEVA | ANDA 073192 | AB | Apr 30, 1992 | |
| LOPERAMIDE HYDROCHLORIDE | ALLIED | ANDA 073079 | — | Apr 30, 1992 | |
| LOPERAMIDE HYDROCHLORIDE | PERRIGO | ANDA 073243 | — | Jan 21, 1992 | |
| LOPERAMIDE HYDROCHLORIDE | ROXANE | ANDA 073080 | — | Nov 27, 1991 | |
| LOPERAMIDE HYDROCHLORIDE | MYLAN | ANDA 072741 | AB | Sep 18, 1991 | |
| LOPERAMIDE HYDROCHLORIDE | TEVA | ANDA 073122 | — | Aug 30, 1991 |
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.
Loperamide hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
