FDA.reportPublic FDA data

anti diarrheal

Product NDC
41250-224
11-digit product format
412500224
Labeler code
41250
Product ID
41250-224_24d1aebe-d698-4529-9850-0bf50ad90366
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Meijer Distribution Inc
Application
ANDA075232
Marketing category
ANDA
Marketing start
2003-03-05
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
2026-12-31

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
41250-224-01anti diarrheal96 in 1 BOTTLETABLET, FILM COATED968
41250-224-01anti diarrheal2 in 1 CARTONTABLET, FILM COATED28
41250-224-53anti diarrheal1 in 1 BLISTER PACKTABLET, FILM COATED18
41250-224-53anti diarrheal12 in 1 CARTONTABLET, FILM COATED128
41250-224-62anti diarrheal24 in 1 CARTONTABLET, FILM COATED248
41250-224-62anti diarrheal1 in 1 BLISTER PACKTABLET, FILM COATED18
41250-224-67anti diarrheal1 in 1 CARTONTABLET, FILM COATED18
41250-224-67anti diarrheal48 in 1 BOTTLETABLET, FILM COATED488
41250-224-80anti diarrheal1 in 1 CARTONTABLET, FILM COATED18
41250-224-80anti diarrheal96 in 1 BOTTLETABLET, FILM COATED968
41250-224-82anti diarrheal1 in 1 CARTONTABLET, FILM COATED18
41250-224-82anti diarrheal200 in 1 BOTTLETABLET, FILM COATED2008
41250-224-91anti diarrheal6 in 1 CARTONTABLET, FILM COATED68
41250-224-91anti diarrheal1 in 1 BLISTER PACKTABLET, FILM COATED18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41250-224-53EA - Each41250-224bb741c79-9f57-4539-a8de-b607611cf78a12015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]3
LOPERAMIDEACTIVE MOIETY6X9OC3H4IIANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-224ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]8Current NDC, Legacy NDC, 14 package rows20240621_06a0530b-b06a-466b-b366-82a2a9f7c05c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSN06a0530b-b06a-466b-b366-82a2a9f7c05c8
978010loperamide hydrochloride 2 MG Oral TabletSCD06a0530b-b06a-466b-b366-82a2a9f7c05c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-224-014125002240196 in 1 BOTTLEHistorical
41250-224-534125002245312 BLISTER PACK in 1 CARTON (41250-224-53) / 1 TABLET, FILM COATED in 1 BLISTER PACK12 blister pack2003-03-240000-00-00NoNoCurrent
41250-224-624125002246224 BLISTER PACK in 1 CARTON (41250-224-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK24 blister pack2024-06-19NoNoHistorical
41250-224-67412500224671 BOTTLE in 1 CARTON (41250-224-67) > 48 TABLET, FILM COATED in 1 BOTTLE1 bottle2004-02-080000-00-00NoNoCurrent
41250-224-80412500224801 in 1 CARTONHistorical
41250-224-82412500224821 BOTTLE in 1 CARTON (41250-224-82) > 200 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-04-010000-00-00NoNoCurrent
41250-224-91412500224916 BLISTER PACK in 1 CARTON (41250-224-91) / 1 TABLET, FILM COATED in 1 BLISTER PACK6 blister pack2016-03-160000-00-00NoNoCurrent