FDA.reportPublic FDA data

Anti Diarrheal

Product NDC
37808-552
11-digit product format
378080552
Labeler code
37808
Product ID
37808-552_27896be5-80e4-4821-8cbe-b1360b850e80
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H E B
Application
ANDA075232
Marketing category
ANDA
Marketing start
2014-05-01
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
37808-552-16Anti Diarrheal72 in 1 BOTTLETABLET, FILM COATED726
37808-552-16Anti Diarrheal2 in 1 CARTONTABLET, FILM COATED26
37808-552-23Anti Diarrheal72 in 1 BOTTLETABLET, FILM COATED726
37808-552-23Anti Diarrheal1 in 1 CARTONTABLET, FILM COATED16
37808-552-53Anti Diarrheal12 in 1 CARTONTABLET, FILM COATED126
37808-552-53Anti Diarrheal1 in 1 BLISTER PACKTABLET, FILM COATED16
37808-552-67Anti Diarrheal1 in 1 CARTONTABLET, FILM COATED16
37808-552-67Anti Diarrheal48 in 1 BOTTLETABLET, FILM COATED486

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [H E B]1
LOPERAMIDEACTIVE MOIETY6X9OC3H4IIANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [H E B]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [H E B]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [H E B]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [H E B]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [H E B]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [H E B]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [H E B]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-552ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [H E B]6Current NDC, Legacy NDC, 8 package rows20241204_8ecbfd81-fe45-49b4-b835-a32192de8f53.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSN8ecbfd81-fe45-49b4-b835-a32192de8f536
978010loperamide hydrochloride 2 MG Oral TabletSCD8ecbfd81-fe45-49b4-b835-a32192de8f536

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-552-163780805521672 in 1 BOTTLEHistorical
37808-552-23378080552231 BOTTLE in 1 CARTON (37808-552-23) > 72 TABLET, FILM COATED in 1 BOTTLE1 bottle2014-05-010000-00-00NoNoCurrent
37808-552-533780805525312 BLISTER PACK in 1 CARTON (37808-552-53) / 1 TABLET, FILM COATED in 1 BLISTER PACK12 blister pack2020-02-200000-00-00NoNoCurrent
37808-552-67378080552671 BOTTLE in 1 CARTON (37808-552-67) > 48 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-06-180000-00-00NoNoCurrent