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 43.

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 3 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-04e64feba35796…
2022-09-29 23:25 UTC2022-09N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-04e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-04cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-04cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-04a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-04a50c72e98297…

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
Imodium A-DLOPERAMIDE HYDROCHLORIDEKenvue Brands LLC31bfcbb4-c58c-4edc-ac68-356a448b75072025-12-22WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
ndc (product): 50580-367
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWALGREENS50814751-8bee-4768-bf6c-e9da3400090b2025-12-15WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
ndc (product): 0363-1176
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDETARGET Corporationee8a6bdf-847e-4b88-8aea-6d3daa6699942025-12-12WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
ndc (product): 11673-177
anti-diarrhealLOPERAMIDE HYDROCHLORIDEMEIJER DISTRIBUTION INC440fb3ce-4106-4169-b187-cfbfdd2f42c12025-12-11WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
ndc (product): 41250-210
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
ndc (product): 53943-176
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEKROGER COMPANYff5dcb48-318c-4f2a-8df2-73ff6dd2a49e2024-12-23WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
ndc (product): 30142-159
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
anti-diarrhealLOPERAMIDE HYDROCHLORIDEBionpharma Inc.a14bd404-cc79-06e0-e053-2a95a90a68412023-12-26WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
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
ndc (product): 36800-208
ANTI-DIARRHEALLOPERAMIDE HYDROCHLORIDENortheast Pharmac2db4155-68d4-71be-e053-2a95a90a7f352022-12-30WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEPremier Value Alliance LLC0dd97bfb-67ce-472f-9b23-15f613bb31352022-12-29WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWal-Mart Stores, Inc.507acd63-b2b4-465e-bb94-2d66724de20a2022-12-29WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
ndc (product): 49035-483

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 121 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWalgreensNDACurrent
0363-0520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWalgreensNDACurrent
0363-1176Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWALGREENSNDACurrent
0363-1176Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWALGREENSNDACurrent
0363-1176Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWALGREENSNDACurrent
0363-1176Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWALGREENSNDACurrent
0363-1176Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWALGREENSNDACurrent
0363-1176Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWALGREENSNDACurrent
11673-177Anti-DiarrhealLOPERAMIDE HYDROCHLORIDETARGET CorporationNDACurrent
11673-177Anti-DiarrhealLOPERAMIDE HYDROCHLORIDETARGET CorporationNDACurrent
11673-520Loperamide HClLOPERAMIDE HYDROCHLORIDETARGET CorporationNDACurrent
11673-520Loperamide HClLOPERAMIDE HYDROCHLORIDETARGET CorporationNDACurrent
11822-7834Anti-DiarrhealLOPERAMIDE HYDROCHLORIDERite Aid CorporationNDACurrent
11822-7834Anti-DiarrhealLOPERAMIDE HYDROCHLORIDERite Aid CorporationNDACurrent
30142-159Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEKROGER COMPANYNDACurrent
30142-159Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEKROGER COMPANYNDACurrent
30142-159Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEKROGER COMPANYNDACurrent
30142-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEThe Kroger Co.NDACurrent
30142-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEThe Kroger Co.NDACurrent
30142-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEThe Kroger Co.NDACurrent
33992-0520Anti-DiarrhealLoperamide HClASSURED / DOLLAR TREE (Greenbrier International, Inc.)NDACurrent
33992-0520Anti-DiarrhealLoperamide HClASSURED / DOLLAR TREE (Greenbrier International, Inc.)NDACurrent
33992-0820Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEASSURED / DOLLAR TREE (Greenbrier International, Inc.)NDACurrent
33992-0820Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEASSURED / DOLLAR TREE (Greenbrier International, Inc.)NDACurrent
33992-0820Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEASSURED / DOLLAR TREE (Greenbrier International, Inc.)NDACurrent
33992-0820Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEASSURED / DOLLAR TREE (Greenbrier International, Inc.)NDACurrent
36800-208Anti-DiarrhealLOPERAMIDE HYDROCHLORIDETOP CARE (Topco Associates LLC)NDACurrent
36800-208Anti-DiarrhealLOPERAMIDE HYDROCHLORIDETOP CARE (Topco Associates LLC)NDACurrent
36800-520Anti-Diarrheal Loperamide HClLOPERAMIDE HYDROCHLORIDETOP CARE (Topco Associates LLC)NDACurrent
36800-520Anti-Diarrheal Loperamide HClLOPERAMIDE HYDROCHLORIDETOP CARE (Topco Associates LLC)NDACurrent
37808-988Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEHEBNDACurrent
37808-988Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEHEBNDACurrent
37808-988Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEHEBNDACurrent
41250-210anti-diarrhealLOPERAMIDE HYDROCHLORIDEMEIJER DISTRIBUTION INCNDACurrent
41250-210anti-diarrhealLOPERAMIDE HYDROCHLORIDEMEIJER DISTRIBUTION INCNDACurrent
41250-210anti-diarrhealLOPERAMIDE HYDROCHLORIDEMEIJER DISTRIBUTION INCNDACurrent
41250-210anti-diarrhealLOPERAMIDE HYDROCHLORIDEMEIJER DISTRIBUTION INCNDACurrent
41250-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEMEIJER, INC.NDACurrent
41250-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEMEIJER, INC.NDACurrent
41250-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEMEIJER, INC.NDACurrent
41520-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECare One (American Sales Company)NDACurrent
41520-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECare One (American Sales Company)NDACurrent
41520-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECare One (American Sales Company)NDACurrent
42507-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEHy-VeeNDACurrent
42507-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEHy-VeeNDACurrent
42507-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEHy-VeeNDACurrent
46122-207Anti-DiarrhealLoperamide HClAmerisourceBergen (Good Neighbor Pharmacy) 46122NDACurrent
46122-207Anti-DiarrhealLoperamide HClAmerisourceBergen (Good Neighbor Pharmacy) 46122NDACurrent
46122-581Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEAMERISOURCE BERGENNDACurrent
46122-581Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEAMERISOURCE BERGENNDACurrent
46122-581Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEAMERISOURCE BERGENNDACurrent
49035-483Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWal-Mart Stores, Inc.NDACurrent
49035-483Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWal-Mart Stores, Inc.NDACurrent
49035-483Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWal-Mart Stores, Inc.NDACurrent
49035-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEEQUATE (Wal-Mart Stores, Inc.)NDACurrent
49035-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEEQUATE (Wal-Mart Stores, Inc.)NDACurrent
49035-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEEQUATE (Wal-Mart Stores, Inc.)NDACurrent
49348-752Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEStrategic Sourcing Services LLCNDACurrent
49348-752Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEMcKesson (Sunmark)NDACurrent
50580-367Imodium A-DLoperamide HydrochlorideJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-367Imodium A-DLoperamide HydrochlorideJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-367Imodium A-DLoperamide HydrochlorideJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-367Imodium A-DLoperamide HydrochlorideJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50804-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEGood Sense (Geiss, Destin & Dunn, Inc.)NDACurrent
50804-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEGood Sense (Geiss, Destin & Dunn, Inc.)NDACurrent
53943-176Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEDISCOUNT DRUG MART, INC.NDACurrent
53943-176Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEDISCOUNT DRUG MART, INC.NDACurrent
53943-176Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEDISCOUNT DRUG MART, INC.NDACurrent
55312-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWestern Family Foods, Inc.NDACurrent
55315-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEFreds IncNDACurrent
55910-176Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEDOLGENCORP, LLCNDACurrent
55910-176Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEDOLGENCORP, LLCNDACurrent
55910-176Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEDOLGENCORP, LLCNDACurrent
55910-176Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEDOLGENCORP, LLCNDACurrent
55910-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)NDACurrent
55910-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)NDACurrent
55910-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)NDACurrent
59726-520Loperamide HCl Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEP & L Development, LLCNDACurrent
59779-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECVS PharmacyNDACurrent
59779-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECVS PharmacyNDACurrent

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