Anti Diarrheal

Product NDC
63868-559
11-digit product format
638680559
Labeler code
63868
Product ID
63868-559_dad3f943-df76-4d9d-8485-495fe14d5a17
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide HCl
Dosage form
TABLET
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC
Application
ANDA076497
Marketing category
ANDA
Marketing start
2005-05-03
Marketing end
2028-01-21
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076497-001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti DiarrhealLOPERAMIDE HCLCHAIN DRUG MARKETING ASSOCIATION INC3d2d211f-546b-48fe-b47c-d4a254f952a32025-02-03WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl. Heart alert: Taking more than directed can cause serious heart problems or death. Do not use if you have bloody or black stool. Ask a doctor before use if you have a fever mucus in the stool a history of liver disease a history of abnormal heart rhythm Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs. When using this product, tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery. Stop use and ask a doctor if symptoms get worse diarrhea lasts for more than 2 days you get abdominal swelling or bulging. These may be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Additional Listing Data#

Finished product
Yes
Brand name base
Anti Diarrheal

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOPERAMIDE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii77TI35393C
Rxcui978010

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
10f838ef-a72b-645d-80f8-e2255205c3b1Product name620240805

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-559-12Anti Diarrheal6 in 1 BLISTER PACKTABLET614
63868-559-12Anti Diarrheal2 in 1 CARTONTABLET214
63868-559-24Anti Diarrheal4 in 1 CARTONTABLET414
63868-559-24Anti Diarrheal6 in 1 BLISTER PACKTABLET614

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-559-12EA - Each63868-559d2b312bf-32c1-4693-8a8c-9e9781d3707e12022-07-06
63868-559-24EA - Each63868-559df89e2c3-8303-4f9c-a9b6-6e47f151f9bb12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-559ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]14Current NDC, Legacy NDC, 4 package rows20250205_3d2d211f-546b-48fe-b47c-d4a254f952a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSN3d2d211f-546b-48fe-b47c-d4a254f952a314
978010loperamide hydrochloride 2 MG Oral TabletSCD3d2d211f-546b-48fe-b47c-d4a254f952a314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-559-12638680559122 BLISTER PACK in 1 CARTON (63868-559-12) / 6 TABLET in 1 BLISTER PACK2 blister pack2005-05-032028-01-21NoNoCurrent
63868-559-24638680559244 BLISTER PACK in 1 CARTON (63868-559-24) / 6 TABLET in 1 BLISTER PACK4 blister pack2005-05-032027-06-27NoNoCurrent