FDA.reportPublic FDA data

Application 091292

Type
ANDA
Sponsor
PERRIGO R AND D

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDESUSPENSION;ORAL1MG/7.5MLNoNo

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
A091292-001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDE1MG/7.5MLSOLUTION / ORAL2011-05-20

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSOLUTION / ORAL2011-05-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSOLUTION / ORAL2011-05-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-203f01610625f2…
2019-09-15 20:21 UTC2019-09A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20cb3db0bc1861…

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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
loperamide hydrochlorideLOPERAMIDE HCLPreferred Pharmaceuticals Inc.0b1f8d41-51b3-4362-8de7-46bca5caff122026-05-28WarningsExact identifier
application applno (ANDA): 091292
application number: ANDA091292
ndc (product): 68788-7842
loperamide hydrochlorideLOPERAMIDE HCLMeijer Distribution Inc5f693cf6-dced-425f-b25e-37a9f8ec17d62026-04-06WarningsExact identifier
application applno (ANDA): 091292
application number: ANDA091292
loperamide hydrochlorideLOPERAMIDE HCLMajor Pharmaceuticalscf5dc855-f0cc-4d7e-8d15-472f7e6544092026-02-13WarningsExact identifier
application applno (ANDA): 091292
application number: ANDA091292
Good Sense antidiarrhealLOPERAMIDE HCLPreferred Pharmaceuticals Inc.672ca656-6abb-42d4-8dbc-9f3428c350582026-01-23WarningsExact identifier
application applno (ANDA): 091292
application number: ANDA091292
Equate Loperamide HydrochlorideLOPERAMIDE HCLWal-Mart Stores Incd8efaddf-4c28-4a7d-af58-42850c7901cd2026-01-19WarningsExact identifier
application applno (ANDA): 091292
application number: ANDA091292
Good Sense antidiarrhealLOPERAMIDE HCLL. Perrigo Company9928de7e-c148-4a19-a946-d4af911c26312025-10-28WarningsExact identifier
application applno (ANDA): 091292
application number: ANDA091292
CareOne Diarrhea ControlLOPERAMIDE HYDROCHLORIDEAmerican Sales Company95ba9c92-77f5-4344-a4f3-78eda9ebc8232025-07-21WarningsExact identifier
application applno (ANDA): 091292
application number: ANDA091292
leader anti diarrhealLOPERAMIDE HCLCardinal Health 110, LLC. dba Leaderf845fad8-6b3c-4c7e-94bc-d4f99f69e4f02025-07-21WarningsExact identifier
application applno (ANDA): 091292
application number: ANDA091292
ndc (product): 70000-0418
basic care loperamide hydrochlorideLOPERAMIDE HYDROCHLORIDEAmazon.com Services LLCf8a3b34a-ee08-466e-ab5f-475f1c2873ec2025-07-17WarningsExact identifier
application applno (ANDA): 091292
application number: ANDA091292
ndc (product): 72288-758
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEPrecision Dose, Inc.ae8237f0-95a6-4163-b476-25c0509ef1512025-06-27WarningsExact identifier
application applno (ANDA): 091292
application number: ANDA091292
ndc (product): 68094-029
ndc (product): 68094-129
equate diarrhea controlLOPERAMIDE HCLWal-Mart Stores Inc53283496-4e65-40ea-8dfb-851ea2c0cc152025-06-19WarningsExact identifier
application applno (ANDA): 091292
application number: ANDA091292
loperamide hydrochlorideLOPERAMIDE HCLATLANTIC BIOLOGICALS CORP.7030f4ed-3cd1-428e-9cae-3b14933d41f52025-05-12WarningsExact identifier
application applno (ANDA): 091292
application number: ANDA091292
Up and Up anti diarrhealLOPERAMIDE HCLTarget Corporation2f5a9854-e1da-4835-9ca4-556a84428e2f2025-04-12WarningsExact identifier
application applno (ANDA): 091292
application number: ANDA091292
leader anti diarrhealLOPERAMIDE HCLCardinal Health 110, LLC. dba Leaderc27e6fbd-8822-4784-9d24-497ae78e54f42025-04-12WarningsExact identifier
application applno (ANDA): 091292
application number: ANDA091292
ndc (product): 70000-0417
DG Health Anti DiarrhealLOPERAMIDE HCLDolgencorp Inc46e3046f-0aea-4848-b5ab-bac4ff0c7f2e2025-04-12WarningsExact identifier
application applno (ANDA): 091292
application number: ANDA091292
foster and thrive anti-diarrhealLOPERAMIDE HCLStrategic Sourcing Services LLCe2074a9b-2702-470c-9112-e67ef5e4905c2025-04-12WarningsExact identifier
application applno (ANDA): 091292
application number: ANDA091292
equaline loperamide hydrochlorideLOPERAMIDE HCLUnited Natural Foods, Inc. dba UNFI9277f433-8b50-4b5b-bfe6-d257d89ebd902025-04-12WarningsExact identifier
application applno (ANDA): 091292
application number: ANDA091292
anti diarrhealLOPERAMIDE HCLKroger Companyff129e3b-6983-4c2f-8c99-dd0e6dc3870f2025-04-11WarningsExact identifier
application applno (ANDA): 091292
application number: ANDA091292
Loperamide hydrochlorideLOPERAMIDE HCLCVS Pharmacy4c620875-1d8d-4170-be93-8649d9d99f4a2025-04-11WarningsExact identifier
application applno (ANDA): 091292
application number: ANDA091292
ndc (product): 69842-191
anti diarrhealLOPERAMIDE HCLH E B01964f8a-f05c-4f72-9530-e0cffd981ffa2025-04-11WarningsExact identifier
application applno (ANDA): 091292
application number: ANDA091292

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 119 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62011-0151health mart loperamide hydrochlorideloperamide HClMcKessonANDACurrent
62011-0151health mart loperamide hydrochlorideloperamide HClStrategic Sourcing Services LLCANDACurrent
62011-0236Health Mart Loperamide HydrochlorideLoperamide HydrochlorideStrategic Sourcing Services LLCANDACurrent
62011-0236Health Mart Loperamide HydrochlorideLoperamide HydrochlorideMcKessonANDACurrent
62011-0383health mart anti diarrhealloperamide HClMcKessonANDACurrent
62011-0383health mart anti diarrhealloperamide HClStrategic Sourcing Services LLCANDACurrent
62011-0383health mart anti diarrhealloperamide HClStrategic Sourcing Services LLCANDACurrent
62011-0385health mart anti diarrhealLoperamide HClStrategic Sourcing Services LLCANDACurrent
62011-0385health mart anti diarrhealLoperamide HClMcKessonANDACurrent
62011-0385health mart anti diarrhealLoperamide HClStrategic Sourcing Services LLCANDACurrent
68094-029Loperamide HydrochlorideLoperamide HydrochloridePrecision Dose, Inc.ANDACurrent
68094-107Loperamide HydrochlorideLoperamide HydrochloridePrecision Dose Inc.ANDACurrent
68094-107Loperamide HydrochlorideLoperamide HydrochloridePrecision Dose Inc.ANDACurrent
68094-108Loperamide HydrochlorideLoperamide HydrochloridePrecision Dose Inc.ANDACurrent
68094-108Loperamide HydrochlorideLoperamide HydrochloridePrecision Dose Inc.ANDACurrent
68094-129Loperamide HydrochlorideLoperamide HydrochloridePrecision Dose, Inc.ANDACurrent
68094-129Loperamide HydrochlorideLoperamide HydrochloridePrecision Dose, Inc.ANDACurrent
68788-7842loperamide hydrochlorideloperamide HClPreferred Pharmaceuticals Inc.ANDACurrent
68788-7842loperamide hydrochlorideloperamide HClPreferred Pharmaceuticals Inc.ANDACurrent
68788-9704loperamide hydrochlorideloperamide HClPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9704loperamide hydrochlorideloperamide HClPreferred Pharmaceuticals, Inc.ANDACurrent
69256-005harris teeter anti diarrhealloperamide HClHarris Teeter, LLCANDACurrent
69256-005harris teeter anti diarrhealloperamide HClHarris Teeter, LLCANDACurrent
69256-645Harris Teeter Loperamide Hydrochlorideloperamide HClHarris Teeter, LLCANDACurrent
69842-191Loperamide hydrochlorideloperamide HClCVS PharmacyANDACurrent
69842-191Loperamide hydrochlorideloperamide HClCVS PharmacyANDACurrent
70000-0224Leader Anti Diarrhealloperamide HClCardinal HealthANDACurrent
70000-0417leader anti diarrhealloperamide HClCardinal HealthANDACurrent
70000-0417leader anti diarrhealloperamide HClCardinal Health 110, LLC. dba LeaderANDACurrent
70000-0417leader anti diarrhealloperamide HClCardinal HealthANDACurrent
70000-0418leader anti diarrhealLoperamide HClCardinal HealthANDACurrent
70000-0418leader anti diarrhealLoperamide HClCardinal Health 110, LLC. dba LeaderANDACurrent
70000-0418leader anti diarrhealLoperamide HClCardinal HealthANDACurrent
70166-087leader loperamideLoperamide HydrochlorideLohxaANDACurrent
70677-0054sunmark anti diarrhealloperamide HClMcKessonANDACurrent
70677-0054sunmark anti diarrhealloperamide HClStrategic Sourcing Services LLCANDACurrent
70677-0054sunmark anti diarrhealloperamide HClStrategic Sourcing Services LLCANDACurrent
72288-645basic care loperamide hydrochlorideloperamide HClAmazon.com Services LLCANDACurrent
72288-758basic care loperamide hydrochlorideLoperamide hydrochlorideAmazon.com Services LLCANDACurrent