FDA.reportPublic FDA data

Application 021855

Type
NDA
Sponsor
BIONPHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDECAPSULE;ORAL1MGYesNo
002LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDECAPSULE;ORAL2MGYesYes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021855-001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-04
N021855-002LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-04

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-045c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-045d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-044b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-0474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-04bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-04782e0a99824c…
2021-12-28 21:50 UTC2021-12N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-04782e0a99824c…

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 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
anti-diarrhealLOPERAMIDE HYDROCHLORIDEAmazon.com Services LLC04a35525-ae8e-b41e-e063-6294a90ab10e2026-04-20WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECVS Pharmacy, Inc.60bc8f05-f35e-45e0-ba3b-c82a87d60f5b2026-02-27WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
ndc (product): 69842-061
Imodium A-DLOPERAMIDE HYDROCHLORIDEKenvue Brands LLC31bfcbb4-c58c-4edc-ac68-356a448b75072025-12-22WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWALGREENS50814751-8bee-4768-bf6c-e9da3400090b2025-12-15WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDETARGET Corporationee8a6bdf-847e-4b88-8aea-6d3daa6699942025-12-12WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
anti-diarrhealLOPERAMIDE HYDROCHLORIDEMEIJER DISTRIBUTION INC440fb3ce-4106-4169-b187-cfbfdd2f42c12025-12-11WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC.35a938af-decf-5b5d-e063-6294a90a9ab02025-05-21WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC.35aa2daf-3486-7ee2-e063-6394a90ad4732025-05-21WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
anti-diarrhealLOPERAMIDE HYDROCHLORIDEAlbertsons Companies1d4ec76d-ff0d-a55d-e063-6294a90ae22c2025-04-07WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEDISCOUNT DRUG MART, INC.ed28814d-9733-46ff-930f-b148e31f2f512024-12-23WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEKROGER COMPANYff5dcb48-318c-4f2a-8df2-73ff6dd2a49e2024-12-23WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
anti-diarrhealLOPERAMIDE HYDROCHLORIDEPUBLIX SUPER MARKETS INC17035ff7-8ba8-131c-e063-6394a90af5ea2024-10-03WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECARDINAL HEALTHbd58d6e9-628c-4c6b-b44c-da95e0417ba72024-05-31WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
ndc (product): 70000-0461
anti-diarrhealLOPERAMIDE HYDROCHLORIDEBionpharma Inc.a14bd404-cc79-06e0-e053-2a95a90a68412023-12-26WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
ndc (product): 69452-266
anti-diarrhealLOPERAMIDE HYDROCHLORIDEVALU MERCHANDISERS COMPANYfed347ad-cfbb-9ee8-e053-6394a90ad2752023-10-10WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDESTRATEGIC SOURCING SERVICESf9e03d2b-2ec0-322b-e053-6394a90a15992023-04-21WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDETOP CARE (Topco Associates LLC)c62bc8d4-0857-16fc-e053-2a95a90a0c412022-12-30WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
ANTI-DIARRHEALLOPERAMIDE HYDROCHLORIDENortheast Pharmac2db4155-68d4-71be-e053-2a95a90a7f352022-12-30WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
ndc (product): 80136-851
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEPremier Value Alliance LLC0dd97bfb-67ce-472f-9b23-15f613bb31352022-12-29WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
ndc (product): 68016-058
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWal-Mart Stores, Inc.507acd63-b2b4-465e-bb94-2d66724de20a2022-12-29WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 121 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59779-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECVS PharmacyNDACurrent
62011-0158Loperamide HClLOPERAMIDE HYDROCHLORIDEMcKesson (Health Mart)NDACurrent
62011-0390Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEStrategic Sourcing Services LLCNDACurrent
62011-0390Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEMCKESSONNDACurrent
62011-0390Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEStrategic Sourcing Services LLCNDACurrent
63868-748Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEQUALITY CHOICE (Chain Drug Marketing Association)NDACurrent
63868-748Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEQUALITY CHOICE (Chain Drug Marketing Association)NDACurrent
63868-748Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEQUALITY CHOICE (Chain Drug Marketing Association)NDACurrent
63868-876Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC.NDACurrent
63868-876Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC.NDACurrent
63868-876Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC.NDACurrent
63868-876Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC.NDACurrent
63941-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEBest Choice (Valu Merchandisers Company)NDACurrent
63941-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEBest Choice (Valu Merchandisers Company)NDACurrent
66715-6859Lil Drug Store Anti-DiarrhealLoperamide HydrochlorideLil' Drug Store Products,NDACurrent
66715-6859Lil Drug Store Anti-DiarrhealLoperamide HydrochlorideLil' Drug Store Products, Inc.NDACurrent
68016-058Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEPremier Value Alliance LLCNDACurrent
68016-058Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEPremier Value Alliance LLCNDACurrent
68016-058Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEPremier Value Alliance LLCNDACurrent
68016-193Loperamide HClLOPERAMIDE HYDROCHLORIDEChain Drug Consortium, LLCNDACurrent
68016-193Loperamide HClLOPERAMIDE HYDROCHLORIDEChain Drug Consortium, LLCNDACurrent
69452-176anti-diarrhealLOPERAMIDE HYDROCHLORIDEBionpharma Inc.NDACurrent
69452-266anti-diarrhealLOPERAMIDE HYDROCHLORIDEBionpharma Inc.NDACurrent
69452-266anti-diarrhealLOPERAMIDE HYDROCHLORIDEBionpharma Inc.NDACurrent
69842-061Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECVS Pharmacy, Inc.NDACurrent
69842-061Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECVS Pharmacy, Inc.NDACurrent
69842-061Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECVS Pharmacy, Inc.NDACurrent
70000-0230Anti-DiarrhealLoperamide HClCardinal Health (Leader) 70000NDACurrent
70000-0230Anti-DiarrhealLoperamide HClCardinal Health (Leader) 70000NDACurrent
70000-0230Anti-DiarrhealLoperamide HClCardinal Health (Leader) 70000NDACurrent
70000-0461Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECARDINAL HEALTHNDACurrent
70000-0461Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECARDINAL HEALTHNDACurrent
70000-0461Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECARDINAL HEALTHNDACurrent
70677-0060Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEMCKESSONNDACurrent
70677-0060Anti-DiarrhealLOPERAMIDE HYDROCHLORIDESTRATEGIC SOURCING SERVICES, LLCNDACurrent
70677-0060Anti-DiarrhealLOPERAMIDE HYDROCHLORIDESTRATEGIC SOURCING SERVICES, LLCNDACurrent
73581-102WELMATE Anti Diarrheal Loperamide HCl SoftgelsLOPERAMIDE HYDROCHLORIDEYYBA CORPNDACurrent
73581-102WELMATE Anti Diarrheal Loperamide HCl SoftgelsLOPERAMIDE HYDROCHLORIDEYYBA CORPNDACurrent
73581-102WELMATE Anti Diarrheal Loperamide HCl SoftgelsLOPERAMIDE HYDROCHLORIDEYYBA CORPNDACurrent
80136-851ANTI-DIARRHEALLOPERAMIDE HYDROCHLORIDENortheast PharmaNDACurrent
80136-851ANTI-DIARRHEALLOPERAMIDE HYDROCHLORIDENortheast PharmaNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63686SUPPL2020-06-24
59327SUPPL2019-07-15
59326SUPPL2019-07-15
47567SUPPL2017-03-16
47547SUPPL2017-03-14
21843ORIG2007-06-04
37765ORIG2005-08-08
6309ORIG2005-08-08