FDA.reportPublic FDA data

anti diarrheal

Product NDC
59779-700
11-digit product format
597790700
Labeler code
59779
Product ID
59779-700_bb2dd75a-8219-405a-93ec-a8116e505cdf
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA075232
Marketing category
ANDA
Marketing start
2003-02-24
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
59779-700-08anti diarrheal1 in 1 CARTONTABLET, FILM COATED19
59779-700-08anti diarrheal108 in 1 BOTTLETABLET, FILM COATED1089
59779-700-53anti diarrheal12 in 1 CARTONTABLET, FILM COATED129
59779-700-53anti diarrheal1 in 1 BLISTER PACKTABLET, FILM COATED19
59779-700-62anti diarrheal12 in 1 CARTONTABLET, FILM COATED129
59779-700-62anti diarrheal2 in 1 BLISTER PACKTABLET, FILM COATED29
59779-700-67anti diarrheal48 in 1 BOTTLETABLET, FILM COATED489
59779-700-67anti diarrheal1 in 1 CARTONTABLET, FILM COATED19
59779-700-68anti diarrheal36 in 1 CARTONTABLET, FILM COATED369
59779-700-68anti diarrheal1 in 1 BLISTER PACKTABLET, FILM COATED19
59779-700-72anti diarrheal1 in 1 CARTONTABLET, FILM COATED19
59779-700-72anti diarrheal60 in 1 BOTTLETABLET, FILM COATED609
59779-700-80anti diarrheal96 in 1 BOTTLETABLET, FILM COATED969
59779-700-80anti diarrheal1 in 1 CARTONTABLET, FILM COATED19
59779-700-82anti diarrheal1 in 1 CARTONTABLET, FILM COATED19
59779-700-82anti diarrheal200 in 1 BOTTLETABLET, FILM COATED2009
59779-700-89anti diarrheal18 in 1 CARTONTABLET, FILM COATED189
59779-700-89anti diarrheal1 in 1 BLISTER PACKTABLET, FILM COATED19
59779-700-91anti diarrheal1 in 1 BLISTER PACKTABLET, FILM COATED19
59779-700-91anti diarrheal6 in 1 CARTONTABLET, FILM COATED69

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-700-53EA - Each59779-7002041046b-da1d-43f0-9c54-920fa153f18b12021-06-02
59779-700-82EA - Each59779-7003ef5af07-4cfd-472c-9c26-7d6c3247ca2e12021-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [CVS PHARMACY]3
LOPERAMIDEACTIVE MOIETY6X9OC3H4IIANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [CVS PHARMACY]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [CVS PHARMACY]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [CVS PHARMACY]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [CVS PHARMACY]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [CVS PHARMACY]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [CVS PHARMACY]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [CVS PHARMACY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-700ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [CVS PHARMACY]9Current NDC, Legacy NDC, 20 package rows20231014_d8a55fb6-bb57-42d6-8e20-67fc91f38097.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSNd8a55fb6-bb57-42d6-8e20-67fc91f380979
978010loperamide hydrochloride 2 MG Oral TabletSCDd8a55fb6-bb57-42d6-8e20-67fc91f380979

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-700-08597790700081 in 1 CARTONHistorical
59779-700-535977907005312 BLISTER PACK in 1 CARTON (59779-700-53) / 1 TABLET, FILM COATED in 1 BLISTER PACK12 blister pack2003-05-120000-00-00NoNoCurrent
59779-700-625977907006212 BLISTER PACK in 1 CARTON (59779-700-62) / 2 TABLET, FILM COATED in 1 BLISTER PACK12 blister pack2022-11-080000-00-00NoNoCurrent
59779-700-67597790700671 BOTTLE in 1 CARTON (59779-700-67) > 48 TABLET, FILM COATED in 1 BOTTLE1 bottle2003-02-240000-00-00NoNoCurrent
59779-700-685977907006836 in 1 CARTONHistorical
59779-700-72597790700721 BOTTLE in 1 CARTON (59779-700-72) > 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2012-02-210000-00-00NoNoCurrent
59779-700-80597790700801 BOTTLE in 1 CARTON (59779-700-80) > 96 TABLET, FILM COATED in 1 BOTTLE1 bottle2004-05-240000-00-00NoNoCurrent
59779-700-82597790700821 BOTTLE in 1 CARTON (59779-700-82) > 200 TABLET, FILM COATED in 1 BOTTLE1 bottle2013-06-180000-00-00NoNoCurrent
59779-700-895977907008918 in 1 CARTONHistorical
59779-700-91597790700911 in 1 BLISTER PACKHistorical