FDA.reportPublic FDA data

Application 017690

Type
NDA
Sponsor
J AND J CONSUMER INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IMODIUMLOPERAMIDE HYDROCHLORIDECAPSULE;ORAL2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017690-001IMODIUMLOPERAMIDE HYDROCHLORIDE2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALApproved before 1982

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N017690-001IMODIUM2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017690-001IMODIUM2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017690-001IMODIUM2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N017690-001IMODIUM2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALApproved before 1982a50c72e98297…

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 1 of 7 · 123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDEYYBA CORP5a728c6d-26ec-3316-e063-6394a90ade082026-09-09WarningsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
anti diarrhealLOPERAMIDE HYDROCHLORIDECVS Pharmacyd8a55fb6-bb57-42d6-8e20-67fc91f380972026-09-04WarningsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDEAurohealth LLCf9a53a23-a8ea-4521-8f0b-1bc2a658ff682026-08-28WarningsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEStrides Pharma, Inc.4178b3cc-e1ca-4912-8b1f-eac0110a39402026-08-13WarningsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEYYBA CORP568064c9-139d-7233-e063-6294a90a10d42026-08-10WarningsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDEREMEDYREPACK INC.3fdfc0e5-56a2-48a0-8ee6-390a194a29f32026-08-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDECardinal Health 107, LLCbe99224e-dd49-4628-a5bf-ed8469ffd4a42026-07-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDECardinal Health 107, LLC74b9893a-18c3-4117-85c2-edab8e7b3b3b2026-07-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEKesin Pharma Corporation52e6ecc5-5f3d-9989-e063-6294a90af2dc2026-06-30WarningsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDESportpharm LLCeb93a17e-7daf-4a9e-94a1-442039a383bd2026-06-26WarningsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDECardinal Health 107, LLCca8de42f-8aea-4e35-ab3a-75ecea718f4f2026-06-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEAurobindo Pharma Limited8e4004be-bf79-4631-9e38-c4e7b67263132026-06-03WarningsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
AMAZON BASIC CARE LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDEProficient Rx LP5e1358fc-76de-486a-80dd-7f41e037d9a02026-06-01WarningsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEBryant Ranch Prepack1e9dfe71-28a9-4b54-a0e1-7c0d82fec0d72026-05-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEPreferred Pharmaceuticals Inc.5b173bb9-3cca-44ce-9bcb-b9ecc93d3dcf2026-05-28WarningsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
Good Sense anti diarrhealLOPERAMIDE HYDROCHLORIDEL. Perrigo Company9c1d811d-f8d0-418c-aaf7-7b6477deea202026-05-20WarningsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDECoupler LLC518bb0f0-88f2-1c95-e063-6294a90a722f2026-05-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEBryant Ranch Prepacka2594967-e737-4a23-a710-290ca0e6a2722026-05-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
berkley and jensen anti diarrhealLOPERAMIDE HYDROCHLORIDEBJWCdc29a8e9-f916-49d2-b9a6-d2b4537d7b582026-05-08WarningsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
MEDIQUE DiamodeLOPERAMIDE HYDROCHLORIDESportpharm LLCac674e5a-94df-4a35-9854-4e66cc17e5092026-04-24WarningsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
45834SUPPL2016-11-08
45822SUPPL2016-11-07