FDA.reportPublic FDA data

anti diarrheal

Product NDC
42507-224
11-digit product format
425070224
Labeler code
42507
Product ID
42507-224_be79f54a-1df5-4acc-9f17-ff7d2559d58f
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
HyVee Inc
Application
ANDA075232
Marketing category
ANDA
Marketing start
2003-03-21
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
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
42507-224-53anti diarrheal12 in 1 CARTONTABLET, FILM COATED124
42507-224-53anti diarrheal1 in 1 BLISTER PACKTABLET, FILM COATED14
42507-224-62anti diarrheal1 in 1 BLISTER PACKTABLET, FILM COATED14
42507-224-62anti diarrheal24 in 1 CARTONTABLET, FILM COATED244
42507-224-80anti diarrheal96 in 1 BOTTLETABLET, FILM COATED964
42507-224-80anti diarrheal1 in 1 CARTONTABLET, FILM COATED14
42507-224-91anti diarrheal6 in 1 CARTONTABLET, FILM COATED64
42507-224-91anti diarrheal1 in 1 BLISTER PACKTABLET, FILM COATED14

DailyMed Socrata Ingredients#

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSN9434cefe-6b13-47c4-b2f7-b8d566c5a4ff4
978010loperamide hydrochloride 2 MG Oral TabletSCD9434cefe-6b13-47c4-b2f7-b8d566c5a4ff4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42507-224-534250702245312 BLISTER PACK in 1 CARTON (42507-224-53) / 1 TABLET, FILM COATED in 1 BLISTER PACK12 blister pack2003-03-21NoNoHistorical
42507-224-624250702246224 BLISTER PACK in 1 CARTON (42507-224-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK24 blister pack2003-03-21NoNoHistorical
42507-224-804250702248096 in 1 BOTTLEHistorical
42507-224-91425070224916 BLISTER PACK in 1 CARTON (42507-224-91) / 1 TABLET, FILM COATED in 1 BLISTER PACK6 blister pack2003-03-21NoNoHistorical