FDA.reportPublic FDA data

Application 074352

Type
ANDA
Sponsor
HI TECH PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDESOLUTION;ORAL1MG/5MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A074352-001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEYYBA CORP568064c9-139d-7233-e063-6294a90a10d42026-07-13WarningsName fallback
brand name: Loperamide Hydrochloride
generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDECardinal Health 107, LLC74b9893a-18c3-4117-85c2-edab8e7b3b3b2026-07-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Loperamide Hydrochloride
generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEKesin Pharma Corporation52e6ecc5-5f3d-9989-e063-6294a90af2dc2026-06-30WarningsName fallback
brand name: Loperamide Hydrochloride
generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDESportpharm LLCeb93a17e-7daf-4a9e-94a1-442039a383bd2026-06-26WarningsName fallback
brand name: Loperamide Hydrochloride
generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDECardinal Health 107, LLCca8de42f-8aea-4e35-ab3a-75ecea718f4f2026-06-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Loperamide Hydrochloride
generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEAurobindo Pharma Limited8e4004be-bf79-4631-9e38-c4e7b67263132026-06-03WarningsName fallback
brand name: Loperamide Hydrochloride
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
brand name: Loperamide Hydrochloride
generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEPreferred Pharmaceuticals Inc.5b173bb9-3cca-44ce-9bcb-b9ecc93d3dcf2026-05-28WarningsName fallback
brand name: Loperamide Hydrochloride
generic name: LOPERAMIDE HYDROCHLORIDE
loperamide hydrochlorideLOPERAMIDE HCLPreferred Pharmaceuticals Inc.0b1f8d41-51b3-4362-8de7-46bca5caff122026-05-28WarningsName fallback
brand 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
brand name: LOPERAMIDE HYDROCHLORIDE
generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEBryant Ranch Prepacka2594967-e737-4a23-a710-290ca0e6a2722026-05-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Loperamide Hydrochloride
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
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEIMO-GEN LABS LLC1b5f2c7c-baf0-b213-e063-6394a90a25df2026-04-21WarningsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
anti-diarrhealLOPERAMIDE HYDROCHLORIDEAmazon.com Services LLC04a35525-ae8e-b41e-e063-6294a90ab10e2026-04-20WarningsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
loperamide hydrochlorideLOPERAMIDE HCLMeijer Distribution Inc5f693cf6-dced-425f-b25e-37a9f8ec17d62026-04-06WarningsName fallback
brand name: loperamide hydrochloride
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEDOLGENCORP INC4db35031-f765-39a6-e063-6394a90a40c92026-03-20WarningsName fallback
brand name: Loperamide Hydrochloride
generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDESafecor Health LLC8b0ac05b-90c1-476b-b001-5801dd21701d2026-03-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Loperamide Hydrochloride
generic name: LOPERAMIDE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17856-0618Loperamide HydrochlorideLoperamide HydrochlorideAtlantic Biologicals CorpsANDACurrent
17856-0618Loperamide HydrochlorideLoperamide HydrochlorideAtlantic Biologicals CorpsANDACurrent
50090-0461Loperamide HydrochlorideLoperamide HydrochlorideA-S Medication SolutionsANDACurrent
50383-618Loperamide HydrochlorideLoperamide HydrochlorideHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-618Loperamide HydrochlorideLoperamide HydrochlorideHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-618Loperamide HydrochlorideLoperamide HydrochlorideAkornANDACurrent
68151-0618Loperamide HydrochlorideLoperamide HydrochlorideCarilion Materials ManagementANDACurrent
68788-9773Loperamide HydrochlorideLoperamide HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9773Loperamide HydrochlorideLoperamide HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9773Loperamide HydrochlorideLoperamide HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9773Loperamide HydrochlorideLoperamide HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent