FDA.reportPublic FDA data

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

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