Application 209837

Type
ANDA
Sponsor
PERRIGO R AND D

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONELOPERAMIDE HYDROCHLORIDE; SIMETHICONETABLET;ORAL2MG;125MGNoNo

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
A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONELOPERAMIDE HYDROCHLORIDE; SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05

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 UTC2026-02A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-053f01610625f2…
2019-09-15 20:21 UTC2019-09A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05cb3db0bc1861…

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 1 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
good sense anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEL. Perrigo Company2cda08a8-3f5e-430c-84a3-d29b97d647af2026-05-20WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
ndc (product): 0113-0087
CareOne Diarrhea and Gas ControlLOPERAMIDE HYDROCHLORIDE, SIMETHICONEAmerican Sales Companydfa3db5a-cef6-4ed5-b9f1-a20b6d1657b32026-04-21WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
ndc (product): 41520-772
anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEHyVee Inc396ea4f5-5c3d-4cbc-acd5-09eb64c806e02026-03-02WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEH E B35cff261-932e-4b2e-ab21-80969c27fa922025-06-27WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
ndc (product): 37808-714
good neighbor pharmacy anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEAmerisource Bergen5dae1247-3ec0-495e-b3f2-1c15551416172025-04-08WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
ndc (product): 46122-620
Anti Diarrheal Anti GasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEKroger Company9c7db942-c8cb-493a-a96f-452b8dfebfc62024-07-23WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
ndc (product): 30142-581
signature care anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONESafeway53829e72-d22c-434d-a108-1972081a6efb2024-07-22WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
ndc (product): 21130-183
anti diarrheal and anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEWalgreen Company0999243a-c3be-41a6-b327-962e63d8c3562024-07-22WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
ndc (product): 0363-1830
dg health anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEDolgencorp, LLC09798231-39cd-49b2-9be5-ea51e52f0a6d2024-07-22WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
ndc (product): 55910-383
Basic Care Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE, SIMETHICONEAmazon.com Services LLCaa79234e-1fbd-4279-b4b1-46b4f041b4e82024-07-22WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
ndc (product): 72288-001
equaline anti diarrheal plus anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEUnited Natural Foods, Inc. dba UNFI2ce0b37e-6dc4-423f-a1d6-a2cb623946d52024-07-22WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
ndc (product): 41163-553
up and up anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONETarget Corporationef75085c-95df-4901-9c97-069fcfc3eef72024-07-22WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
ndc (product): 11673-646
anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONERite Aid Corporation8e954f86-bc15-45e2-9274-ca5d8a7c96872024-07-22WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
ndc (product): 11822-1003
anti diarrheal and anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONECVS Pharmacy065699b5-217e-432f-a253-cea2d3f622332024-07-20WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
ndc (product): 69842-644
Good Sense Anti Diarrheal Anti GasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEL. Perrigo Companyfcfd0b64-6876-4e6f-8a7b-ca1da9e03f002024-07-13WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
ndc (product): 0113-1087
anti diarrheal plus anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEMeijer Distribution Ince2c9a752-618a-4e34-89a5-671aab4013ac2024-07-11WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
ndc (product): 41250-375
foster and thrive anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEStrategic Sourcing Services LLC9132dc1c-8e16-4236-881e-863f5e57f0ab2024-07-08WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 57 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-0087good sense anti diarrheal anti gasloperamide hydrochloride, simethiconeL. Perrigo CompanyANDACurrent
0113-0087good sense anti diarrheal anti gasloperamide hydrochloride, simethiconeL Perrigo CompanyANDACurrent
0113-1087Good Sense Anti Diarrheal Anti Gasloperamide hydrochloride, simethiconeL. Perrigo CompanyANDACurrent
0113-7119basic care loperamide hydrochloride and simethiconeloperamide hydrochloride, simethiconeL. Perrigo CompanyANDACurrent
0113-7119basic care loperamide hydrochloride and simethiconeloperamide hydrochloride, simethiconeL. Perrigo CompanyANDACurrent
0363-1830anti diarrheal and anti gasloperamide hydrochloride, simethiconeWalgreen CompanyANDACurrent
0363-1830anti diarrheal and anti gasloperamide hydrochloride, simethiconeWalgreen CompanyANDACurrent
0363-1830anti diarrheal and anti gasloperamide hydrochloride, simethiconeWalgreen CompanyANDACurrent
11673-646up and up anti diarrheal anti gasloperamide hydrochloride, simethiconeTarget CorporationANDACurrent
11673-646up and up anti diarrheal anti gasloperamide hydrochloride, simethiconeTarget CorporationANDACurrent
11673-646up and up anti diarrheal anti gasloperamide hydrochloride, simethiconeTarget CorporationANDACurrent
11822-1003anti diarrheal anti gasloperamide hydrochloride, simethiconeRite Aid CorporationANDACurrent
11822-1003anti diarrheal anti gasloperamide hydrochloride, simethiconeRite Aid CorporationANDACurrent
21130-183signature care anti diarrheal anti gasloperamide hydrochloride, simethiconeSafewayANDACurrent
21130-183signature care anti diarrheal anti gasloperamide hydrochloride, simethiconeSafewayANDACurrent
21130-183signature care anti diarrheal anti gasloperamide hydrochloride, simethiconeSafewayANDACurrent
30142-581Anti Diarrheal Anti GasLoperamide Hydrochloride, SimethiconeKroger CompanyANDACurrent
30142-581Anti Diarrheal Anti GasLoperamide Hydrochloride, SimethiconeKroger CompanyANDACurrent
36800-633topcare anti diarrheal anti gasloperamide hydrochloride, simethiconeTopco Associates LLCANDACurrent
36800-633topcare anti diarrheal anti gasloperamide hydrochloride, simethiconeTopco Associates LLCANDACurrent
36800-633topcare anti diarrheal anti gasloperamide hydrochloride, simethiconeTopco Associates LLCANDACurrent
36800-633topcare anti diarrheal anti gasloperamide hydrochloride, simethiconeTopco Associates LLCANDACurrent
37808-714anti diarrheal anti gasloperamide hydrochloride, simethiconeH E BANDACurrent
37808-714anti diarrheal anti gasloperamide hydrochloride, simethiconeH E BANDACurrent
37808-714anti diarrheal anti gasloperamide hydrochloride, simethiconeH E BANDACurrent
41163-553equaline anti diarrheal plus anti gasloperamide hydrochloride, simethiconeSupervalu IncANDACurrent
41250-375anti diarrheal plus anti gasloperamide hydrochloride, simethiconeMeijer Distribution IncANDACurrent
41250-375anti diarrheal plus anti gasloperamide hydrochloride, simethiconeMeijer Distribution IncANDACurrent
41250-375anti diarrheal plus anti gasloperamide hydrochloride, simethiconeMeijer Distribution IncANDACurrent
41520-772CareOne Diarrhea and Gas Controlloperamide hydrochloride, simethiconeAmerican Sales CompanyANDACurrent
41520-772CareOne Diarrhea and Gas Controlloperamide hydrochloride, simethiconeAmerican Sales CompanyANDACurrent
46122-566Anti Diarrheal Anti Gasloperamide hydrochloride, simethiconeAmerisource BergenANDACurrent
46122-566Anti Diarrheal Anti Gasloperamide hydrochloride, simethiconeAmerisource BergenANDACurrent
46122-620good neighbor pharmacy anti diarrheal anti gasloperamide hydrochloride, simethiconeAmerisource BergenANDACurrent
46122-620good neighbor pharmacy anti diarrheal anti gasloperamide hydrochloride, simethiconeAmerisource BergenANDACurrent
49035-549equate anti diarrheal anti gasloperamide hydrochloride, simethiconeWal-Mart Stores IncANDACurrent
49035-549equate anti diarrheal anti gasloperamide hydrochloride, simethiconeWal-Mart Stores IncANDACurrent
49035-549equate anti diarrheal anti gasloperamide hydrochloride, simethiconeWal-Mart Stores IncANDACurrent
55319-106family wellness anti diarrheal plus multi symptom reliefloperamide hydrochloride, simethiconeFamily Dollar Services IncANDACurrent
55319-823family wellness anti diarrheal plus anti gasloperamide hydrochloride, simethiconeFamily Dollar Services IncANDACurrent
55319-823family wellness anti diarrheal plus anti gasloperamide hydrochloride, simethiconeFamily Dollar Services IncANDACurrent
55319-823family wellness anti diarrheal plus anti gasloperamide hydrochloride, simethiconeFamily Dollar Services IncANDACurrent
55910-383dg health anti diarrheal anti gasloperamide hydrochloride, simethiconeDolgencorp, LLCANDACurrent
55910-383dg health anti diarrheal anti gasloperamide hydrochloride, simethiconeDolgencorp, LLCANDACurrent
55910-383dg health anti diarrheal anti gasloperamide hydrochloride, simethiconeDolgencorp, LLCANDACurrent
55910-383dg health anti diarrheal anti gasloperamide hydrochloride, simethiconeDolgencorp, LLCANDACurrent
56062-511antidiarrheal multi symptom reliefloperamide hydrochloride, simethiconePublix Super Markets IncANDACurrent
62011-0365health mart anti diarrheal anti gasloperamide hydrochloride, simethiconeStrategic Sourcing Services LLCANDACurrent
62011-0365health mart anti diarrheal anti gasloperamide hydrochloride, simethiconeMckessonANDACurrent
62011-0365health mart anti diarrheal anti gasloperamide hydrochloride, simethiconeMckessonANDACurrent
62011-0365health mart anti diarrheal anti gasloperamide hydrochloride, simethiconeStrategic Sourcing Services LLCANDACurrent
69842-644anti diarrheal and anti gasloperamide hydrochloride, simethiconeCVS PharmacyANDACurrent
69842-644anti diarrheal and anti gasloperamide hydrochloride, simethiconeCVS PharmacyANDACurrent
69842-807loperamide hydrochloride and simethiconeloperamide hydrochloride, simethiconeCVS PharmacyANDACurrent
69842-807loperamide hydrochloride and simethiconeloperamide hydrochloride, simethiconeCVS PharmacyANDACurrent
72288-001Basic Care Loperamide Hydrochloride and Simethiconeloperamide hydrochloride, simethiconeAmazon.com Services LLCANDACurrent
72288-001Basic Care Loperamide Hydrochloride and Simethiconeloperamide hydrochloride, simethiconeAmazon.com Services Inc.ANDACurrent