sunmark loperamide hydrochloride

Product NDC
49348-999
11-digit product format
493480999
Labeler code
49348
Product ID
49348-999_b75d9e85-5ea9-4ac1-8f51-374d54a9b649
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide HCl
Dosage form
SUSPENSION
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA091292
Marketing category
ANDA
Marketing start
2014-02-18
Marketing end
0000-00-00
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
1 mg/7.5mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49348-999DDiscontinued by firm2026-08-03
excluded packagepackage49348-99949348-999-34DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49348-999-34d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49348-999-34f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49348-999-342ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49348-999-34a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49348-999-34cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49348-999-34cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49348-999-34302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49348-999-34ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49348-999-340efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49348-999-34ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49348-999-34367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49348-999-34557ba5c1ecfa…9c80585c8c6e…

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…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-999-34ML - Milliliter49348-999660d0c25-bc7a-4c54-9233-a4d41bb1d36e12014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CSUNMARK LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [MCKESSON]1
LOPERAMIDEACTIVE MOIETY6X9OC3H4IISUNMARK LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [MCKESSON]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLSUNMARK LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [MCKESSON]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311SUNMARK LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [MCKESSON]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUNMARK LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [MCKESSON]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSUNMARK LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [MCKESSON]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSUNMARK LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [MCKESSON]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSUNMARK LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [MCKESSON]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SUNMARK LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [MCKESSON]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSUNMARK LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [MCKESSON]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4SUNMARK LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [MCKESSON]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSUNMARK LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [MCKESSON]1
WATERINACTIVE INGREDIENT059QF0KO0RSUNMARK LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [MCKESSON]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESUNMARK LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [MCKESSON]1

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
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
basic care loperamide hydrochlorideLOPERAMIDE HYDROCHLORIDEAmazon.com Services LLCf8a3b34a-ee08-466e-ab5f-475f1c2873ec2025-07-17WarningsExact identifier
application applno (ANDA): 091292
application number: ANDA091292
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEPrecision Dose, Inc.ae8237f0-95a6-4163-b476-25c0509ef1512025-06-27WarningsExact identifier
application applno (ANDA): 091292
application number: ANDA091292
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
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
anti diarrhealLOPERAMIDE HCLH E B01964f8a-f05c-4f72-9530-e0cffd981ffa2025-04-11WarningsExact identifier
application applno (ANDA): 091292
application number: ANDA091292

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-999-3449348099934120 mL in 1 BOTTLE (49348-999-34) 120 ml2014-02-180000-00-00NoNoCurrent