Home Applications 019860 Application 019860
Type NDA
Sponsor J AND J CONSUMER INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IMODIUM A-D LOPERAMIDE HYDROCHLORIDE TABLET;ORAL 2MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019860-001 IMODIUM A-D LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL RLD, RS 1989-11-22
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019860-001 IMODIUM A-D 2MG TABLET / ORAL RLD, RS 1989-11-22 f41ea6bd6efb…
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 5 of 7 · 124 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE NuCare Pharmaceuticals,Inc. df4e7076-fd25-aeb8-e053-2995a90a2aa0 2024-05-07 Boxed warning, Warnings, Adverse reactions Name fallback generic name: LOPERAMIDE HYDROCHLORIDE Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE SDA Laboratories, Inc. d954ff63-f096-45e8-a0b6-f22e323b113f 2024-04-18 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Bryant Ranch Prepack 691c5dd6-b85d-482b-a8c1-8c4b48b48dc9 2024-04-03 Boxed warning, Warnings, Adverse reactions Name fallback generic name: LOPERAMIDE HYDROCHLORIDE Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Amerisource Bergen 6c15f077-9f90-4262-9c17-a1ac70e45f57 2024-03-29 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC c5322892-cb14-4a25-9b42-e62e491bc101 2024-02-01 Boxed warning, Warnings, Adverse reactions Name fallback generic name: LOPERAMIDE HYDROCHLORIDE Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Chain Drug Consortium, LLC b070896b-1e22-41d4-a66d-8d3be1699217 2024-01-11 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Zee Medical Inc 07e1f89c-5bf6-4539-848a-4435e7deb0d2 2024-01-11 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Ohm Laboratories Inc. c26c15a1-3a8a-4562-8c5e-ebbc8b81e0c6 2024-01-11 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Discount Drug Mart 6bc9771d-09f8-47ce-bbbd-8dd9aae97693 2024-01-11 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Marc Glassman, Inc. 01efdce1-25ce-45ff-aeb6-f6fba00e59aa 2024-01-11 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Valu Merchandisers Company 33335063-49a9-4e08-9d77-4cd80e94f021 2024-01-11 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Fred's Inc. a3bf91ae-22f3-4402-b73c-de026f2d0475 2024-01-11 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Chain Drug Marketing Association Inc. 237b845b-0f02-410d-9750-c95123e6142d 2024-01-11 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Bionpharma Inc. 6e60cb25-6af9-4f17-b740-a5e7b5bb2a09 2023-12-27 Boxed warning, Warnings, Adverse reactions Name fallback generic name: LOPERAMIDE HYDROCHLORIDE anti-diarrheal LOPERAMIDE HYDROCHLORIDE Bionpharma Inc. a14bd404-cc79-06e0-e053-2a95a90a6841 2023-12-26 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE anti-diarrheal LOPERAMIDE HYDROCHLORIDE VALU MERCHANDISERS COMPANY fed347ad-cfbb-9ee8-e053-6394a90ad275 2023-10-10 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE Aurobindo Pharma Limited 8d142533-4e87-4030-8fe9-4fc7473b0442 2023-09-11 Boxed warning, Warnings, Adverse reactions Name fallback generic name: LOPERAMIDE HYDROCHLORIDE Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Dr. Reddy's Laboratories Inc. 6fe91ddc-06b6-3a51-2b48-f6f11361ab73 2023-06-25 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Dr. Reddy's Laboratories Inc. 356d9432-d948-4b88-b297-9161b845f86b 2023-06-25 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE Loperamide hydrochloride LOPERAMIDE HYDROCHLORIDE Viona Pharmaceuticals Inc 330677ff-5426-40bd-af45-e3836cb77893 2023-06-19 Boxed warning, Warnings, Adverse reactions Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 66715-9720 Imodium AD Loperamide Hydrochloride Lil' Drug Store Products, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 57941 SUPPL 2019-03-08 57934 SUPPL 2019-03-08 48030 SUPPL 2017-04-14 48012 SUPPL 2017-04-13 1732 SUPPL 2012-05-08 41070 SUPPL 2008-07-31 19779 SUPPL 2004-06-16 1731 SUPPL 2001-04-11