Anti-Diarrheal

Product NDC
55319-375
11-digit product format
553190375
Labeler code
55319
Product ID
55319-375_b2a60e21-e02e-4899-b1d5-c4697e3a3a63
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide HCl
Dosage form
TABLET
Route
ORAL
Labeler
Family Dollar Services Inc
Application
ANDA076497
Marketing category
ANDA
Marketing start
2005-05-03
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Anti-Diarrheal
Listing expiration
2027-12-31

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
55319-375-08Anti-Diarrheal4 in 1 CARTONTABLET424
55319-375-08Anti-Diarrheal6 in 1 BLISTER PACKTABLET624
55319-375-12Anti-Diarrheal2 in 1 CARTONTABLET224
55319-375-12Anti-Diarrheal6 in 1 BLISTER PACKTABLET624

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [FAMILY DOLLAR]4
LOPERAMIDEACTIVE MOIETY6X9OC3H4IIANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [FAMILY DOLLAR]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [FAMILY DOLLAR]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [FAMILY DOLLAR]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [FAMILY DOLLAR]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-375ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [FAMILY DOLLAR SERVICES INC]24Current NDC, Legacy NDC, 4 package rows20250529_769e7182-fa11-4645-8fca-657253f28d9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSN769e7182-fa11-4645-8fca-657253f28d9c25
978010loperamide hydrochloride 2 MG Oral TabletSCD769e7182-fa11-4645-8fca-657253f28d9c25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55319-375-08553190375084 BLISTER PACK in 1 CARTON (55319-375-08) / 6 TABLET in 1 BLISTER PACK4 blister pack2005-05-030000-00-00NoNoCurrent
55319-375-12553190375122 BLISTER PACK in 1 CARTON (55319-375-12) / 6 TABLET in 1 BLISTER PACK2 blister pack2005-05-030000-00-00NoNoCurrent