Application 076497

Type
ANDA
Sponsor
LNK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDETABLET;ORAL2MGNoNo

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
A076497-001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10

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 UTC2026-02A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-103f01610625f2…
2019-09-15 20:21 UTC2019-09A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10cb3db0bc1861…

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 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti DiarrhealLOPERAMIDE HCLYyba Corpe3b0a274-8bf9-4d39-a805-97fecca607f62026-07-13WarningsExact identifier
application applno (ANDA): 076497
application number: ANDA076497
Anti-DiarrhealLOPERAMIDE HCLWalgreen Company31f9b652-e9c9-46ed-a46c-22d30ad110042026-07-10WarningsExact identifier
application applno (ANDA): 076497
application number: ANDA076497
Anti-diarrhealLOPERAMIDE HCLL.N.K. International, Inc.e34f5bbc-e43c-a69e-e94d-ebc3195182042026-06-23WarningsExact identifier
application applno (ANDA): 076497
application number: ANDA076497
Anti-DiarrhealLOPERAMIDE HCLDiscount Drug Mart91843b17-3c04-482c-a2ba-143193be15952026-06-08WarningsExact identifier
application applno (ANDA): 076497
application number: ANDA076497
ndc (product): 53943-375
Anti DiarrhealLOPERAMIDE HCLARMY AND AIR FORCE EXCHANGE SERVICEf93a1f1f-2233-4338-9643-1ba48bd000bc2026-06-03WarningsExact identifier
application applno (ANDA): 076497
application number: ANDA076497
ndc (product): 55301-375
Anti-DiarrhealLOPERAMIDE HCLFamily Dollar Services Inc769e7182-fa11-4645-8fca-657253f28d9c2026-05-27WarningsExact identifier
application applno (ANDA): 076497
application number: ANDA076497
ndc (product): 55319-375
Anti-DiarrhealLOPERAMIDE HCLH E B8f7fea50-70cf-4f9f-a655-30371e5b9d9f2026-05-19WarningsExact identifier
application applno (ANDA): 076497
application number: ANDA076497
Anti DiarrhealLOPERAMIDE HCLChain Drug Marketing Association, Inc.dd993f38-a31f-4739-9496-e14186a890532026-05-18WarningsExact identifier
application applno (ANDA): 076497
application number: ANDA076497
Anti-DiarrhealLOPERAMIDE HCLUnited Natural Foods, Inc. dba UNFIf16e07f3-0efb-4451-adbb-e427f9abc7ae2026-05-18WarningsExact identifier
application applno (ANDA): 076497
application number: ANDA076497
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEIMO-GEN LABS LLC1b5f2c7c-baf0-b213-e063-6394a90a25df2026-04-21WarningsExact identifier
application applno (ANDA): 076497
application number: ANDA076497
Anti-DiarrhealLOPERAMIDE HCLValu Merchandisers Company70a7f827-f5be-454f-99bf-a7fd1037694e2026-04-21WarningsExact identifier
application applno (ANDA): 076497
application number: ANDA076497
ndc (product): 63941-375
Anti-DiarrhealLOPERAMIDE HCLWinCo Foods, LLC3990279b-45ee-49cf-9ecf-9ce23731b59a2026-04-17WarningsExact identifier
application applno (ANDA): 076497
application number: ANDA076497
ndc (product): 67091-335
Anti-DiarrhealLOPERAMIDE HCLHeartland Pharma Co.e360ba61-556a-4d7f-ab2e-2cb71656d8682026-04-17WarningsExact identifier
application applno (ANDA): 076497
application number: ANDA076497
Anti-DiarrhealLOPERAMIDE HCLGrocery Outlet94279e1f-5d87-40ba-8b4b-56930fdc3e3a2026-03-19WarningsExact identifier
application applno (ANDA): 076497
application number: ANDA076497
Anti-DiarrhealLOPERAMIDE HCLRite Aid Corporationc6cc4ba7-0e7a-4dd6-a5cf-b7e16e1a6c752026-03-11WarningsExact identifier
application applno (ANDA): 076497
application number: ANDA076497
Anti DiarrhealLOPERAMIDE HCLWal-Mart Stores Incb480916e-6383-468d-9e3e-499efea925222026-01-19WarningsExact identifier
application applno (ANDA): 076497
application number: ANDA076497
ANTI-DIARRHEALLOPERAMIDE HCLAdvanced Rx LLC148cb6b7-28e7-48e9-b464-f42daa90e5da2025-11-04WarningsExact identifier
application applno (ANDA): 076497
application number: ANDA076497
Anti-DiarrhealLOPERAMIDE HCLBetter Living Brands, LLC8d3ccda2-3886-4ff7-ad10-6440fc4da6bf2025-10-28WarningsExact identifier
application applno (ANDA): 076497
application number: ANDA076497
Anti-DiarrhealLOPERAMIDE HCLL.N.K. International, Inc.c03a9389-8b33-4ade-8ba0-8f303e161a082025-10-06WarningsExact identifier
application applno (ANDA): 076497
application number: ANDA076497
First Aid Direct Anti-DiarrhealFIRST AID DIRECT ANTI-DIARRHEALCintas Corp942b5af1-835e-41dd-bf65-e5b68352aa462025-09-29WarningsExact identifier
application applno (ANDA): 076497
application number: ANDA076497

NDC Listings For This Application#

NDC listings for this application page 2 of 3 · 177 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50844-735Loperamide HClLoperamide HClL.N.K. International, Inc.ANDACurrent
50844-753Anti DiarrhealLoperamide HClL.N.K. International, Inc.ANDACurrent
50844-753Anti DiarrhealLoperamide HClL.N.K. International, Inc.ANDACurrent
50844-753Anti DiarrhealLoperamide HClL.N.K. International, Inc.ANDACurrent
50844-753Anti DiarrhealLoperamide HClL.N.K. International, Inc.ANDACurrent
50844-753Anti DiarrhealLoperamide HClL.N.K. International, Inc.ANDACurrent
50844-753Anti DiarrhealLoperamide HClL.N.K. International, Inc.ANDACurrent
50844-753Anti DiarrhealLoperamide HClL.N.K. International, Inc.ANDACurrent
53117-248Anti-DiarrhealLoperamide HClFirst Aid DirectANDACurrent
53117-248Anti-DiarrhealLoperamide HClFirst Aid DirectANDACurrent
53943-375Anti-DiarrhealLoperamide HClDiscount Drug MartANDACurrent
53943-375Anti-DiarrhealLoperamide HClDiscount Drug MartANDACurrent
53943-375Anti-DiarrhealLoperamide HClDiscount Drug MartANDACurrent
53943-375Anti-DiarrhealLoperamide HClDiscount Drug MartANDACurrent
55301-375Anti DiarrhealLoperamide HClARMY AND AIR FORCE EXCHANGE SERVICEANDACurrent
55301-375Anti DiarrhealLoperamide HClARMY AND AIR FORCE EXCHANGE SERVICEANDACurrent
55301-375Anti DiarrhealLoperamide HClARMY AND AIR FORCE EXCHANGE SERVICEANDACurrent
55301-375Anti DiarrhealLoperamide HClARMY AND AIR FORCE EXCHANGE SERVICEANDACurrent
55301-375Anti DiarrhealLoperamide HClARMY AND AIR FORCE EXCHANGE SERVICEANDACurrent
55301-375Anti DiarrhealLoperamide HClARMY AND AIR FORCE EXCHANGE SERVICEANDACurrent
55301-375Anti DiarrhealLoperamide HClARMY AND AIR FORCE EXCHANGE SERVICEANDACurrent
55301-375Anti DiarrhealLoperamide HClARMY AND AIR FORCE EXCHANGE SERVICEANDACurrent
55301-375Anti DiarrhealLoperamide HClARMY AND AIR FORCE EXCHANGE SERVICEANDACurrent
55315-975Anti-DiarrhealLoperamide HClFRED'S, INC.ANDACurrent
55315-975Anti-DiarrhealLoperamide HClFRED'S, INC.ANDACurrent
55315-975Anti-DiarrhealLoperamide HClFRED'S, INC.ANDACurrent
55319-375Anti-DiarrhealLoperamide HClFamily Dollar Services IncANDACurrent
55319-375Anti-DiarrhealLoperamide HClFamily Dollar Services IncANDACurrent
55319-375Anti-DiarrhealLoperamide HClFamily Dollar Services IncANDACurrent
55319-375Anti-DiarrhealLoperamide HClFamily Dollar Services IncANDACurrent
55319-375Anti-DiarrhealLoperamide HClFamily Dollar Services IncANDACurrent
55319-375Anti-DiarrhealLoperamide HClFamily Dollar Services IncANDACurrent
55319-375Anti-DiarrhealLoperamide HClFamily Dollar Services IncANDACurrent
55319-375Anti-DiarrhealLoperamide HClFamily Dollar Services IncANDACurrent
55319-375Anti-DiarrhealLoperamide HClFamily Dollar Services IncANDACurrent
57896-381Anti-DiarrhealLoperamide HClGeri-Care Pharmaceutical CorpANDACurrent
57896-381Anti-DiarrhealLoperamide HClGeri-Care Pharmaceutical CorpANDACurrent
57896-381Anti-DiarrhealLoperamide HClGeri-Care Pharmaceutical CorpANDACurrent
57896-381Anti-DiarrhealLoperamide HClGeri-Care Pharmaceutical CorpANDACurrent
57896-381Anti-DiarrhealLoperamide HClGeri-Care Pharmaceutical CorpANDACurrent
63868-559Anti DiarrhealLoperamide HClCHAIN DRUG MARKETING ASSOCIATION INCANDACurrent
63868-559Anti DiarrhealLoperamide HClCHAIN DRUG MARKETING ASSOCIATION INCANDACurrent
63868-559Anti DiarrhealLoperamide HClCHAIN DRUG MARKETING ASSOCIATION INCANDACurrent
63868-559Anti DiarrhealLoperamide HClCHAIN DRUG MARKETING ASSOCIATION INCANDACurrent
63868-559Anti DiarrhealLoperamide HClCHAIN DRUG MARKETING ASSOCIATION INCANDACurrent
63868-559Anti DiarrhealLoperamide HClCHAIN DRUG MARKETING ASSOCIATION INCANDACurrent
63868-559Anti DiarrhealLoperamide HClCHAIN DRUG MARKETING ASSOCIATION INCANDACurrent
63868-559Anti DiarrhealLoperamide HClCHAIN DRUG MARKETING ASSOCIATION INCANDACurrent
63940-375Anti DiarrhealLoperamide HClHarmon Store Inc.ANDACurrent
63940-375Anti DiarrhealLoperamide HClHarmon Store Inc.ANDACurrent
63940-375Anti DiarrhealLoperamide HClHarmon Store Inc.ANDACurrent
63941-375Anti-DiarrhealLoperamide HClValu Merchandisers CompanyANDACurrent
63941-375Anti-DiarrhealLoperamide HClValu Merchandisers CompanyANDACurrent
63941-375Anti-DiarrhealLoperamide HClValu Merchandisers CompanyANDACurrent
63941-375Anti-DiarrhealLoperamide HClValu Merchandisers CompanyANDACurrent
64092-105Anti-DiarrhealLoperamide HClGREAT LAKES WHOLESALE, MARKETING, & SALES, INC.ANDACurrent
64092-105Anti-DiarrhealLoperamide HClGREAT LAKES WHOLESALE, MARKETING, & SALES, INC.ANDACurrent
64092-105Anti-DiarrhealLoperamide HClGREAT LAKES WHOLESALE, MARKETING, & SALES, INC.ANDACurrent
64092-105Anti-DiarrhealLoperamide HClGREAT LAKES WHOLESALE, MARKETING, & SALES, INC.ANDACurrent
64092-105Anti-DiarrhealLoperamide HClGREAT LAKES WHOLESALE, MARKETING, & SALES, INC.ANDACurrent
64092-105Anti-DiarrhealLoperamide HClGREAT LAKES WHOLESALE, MARKETING, & SALES, INC.ANDACurrent
66424-735ANTI-DIARRHEAL LOPERAMIDE HCL, 2 mg capletsLoperamide HCLSDA Laboratories, Inc.ANDACurrent
66424-735ANTI-DIARRHEAL LOPERAMIDE HCL, 2 mg capletsLoperamide HCLSDA Laboratories, Inc.ANDACurrent
66424-735ANTI-DIARRHEAL LOPERAMIDE HCL, 2 mg capletsLoperamide HCLSDA Laboratories, Inc.ANDACurrent
66424-735ANTI-DIARRHEAL LOPERAMIDE HCL, 2 mg capletsLoperamide HCLSDA Laboratories, Inc.ANDACurrent
67091-335Anti-DiarrhealLoperamide HClWinCo Foods, LLCANDACurrent
67091-335Anti-DiarrhealLoperamide HClWinCo Foods, LLCANDACurrent
67091-335Anti-DiarrhealLoperamide HClWinCo Foods, LLCANDACurrent
67091-335Anti-DiarrhealLoperamide HClWinCo Foods, LLCANDACurrent
67091-335Anti-DiarrhealLoperamide HClWinCo Foods, LLCANDACurrent
67091-405Anti DiarrhealLoperamide HCLWinCo FoodsANDACurrent
68016-301Anti-diarrhealLoperamide HClChain Drug ConsortiumANDACurrent
68016-301Anti-diarrhealLoperamide HClChain Drug ConsortiumANDACurrent
68016-301Anti-diarrhealLoperamide HClChain Drug ConsortiumANDACurrent
68016-301Anti-diarrhealLoperamide HClChain Drug ConsortiumANDACurrent
68016-638Anti-diarrhealLoperamide HClChain Drug ConsortiumANDACurrent
68016-638Anti-diarrhealLoperamide HClChain Drug ConsortiumANDACurrent
68196-975anti-diarrhealLoperamide HClSam's West IncANDACurrent
68196-975anti-diarrhealLoperamide HClSam's West IncANDACurrent
68196-975anti-diarrhealLoperamide HClSam's West IncANDACurrent