FDA.reportPublic FDA data

Imodium

Product NDC
50580-317
11-digit product format
505800317
Labeler code
50580
Product ID
50580-317_3f75a619-8881-0bb3-e063-6394a90a1bcc
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Kenvue Brands LLC
Application
ANDA075232
Marketing category
ANDA
Marketing start
2015-07-13
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
Imodium
Brand name suffix
A-D
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOPERAMIDE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii77TI35393C
Rxcui978010, 978013

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
50580-317-01ImodiumA-D1 in 1 CARTONTABLET, FILM COATED113
50580-317-01ImodiumA-D6 in 1 BLISTER PACKTABLET, FILM COATED613
50580-317-03ImodiumA-D6 in 1 BLISTER PACKTABLET, FILM COATED613
50580-317-03ImodiumA-D4 in 1 CARTONTABLET, FILM COATED413
50580-317-04ImodiumA-D6 in 1 BLISTER PACKTABLET, FILM COATED613
50580-317-04ImodiumA-D6 in 1 CARTONTABLET, FILM COATED613
50580-317-05ImodiumA-D8 in 1 CARTONTABLET, FILM COATED813
50580-317-05ImodiumA-D6 in 1 BLISTER PACKTABLET, FILM COATED613
50580-317-06ImodiumA-D6 in 1 BLISTER PACKTABLET, FILM COATED613
50580-317-06ImodiumA-D2 in 1 CARTONTABLET, FILM COATED213
50580-317-12ImodiumA-D6 in 1 BLISTER PACKTABLET, FILM COATED613
50580-317-12ImodiumA-D2 in 1 CARTONTABLET, FILM COATED213

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-317-01EA - Each50580-317901b41ea-be09-4f0e-84e7-1e4229c3185312024-04-05
50580-317-03EA - Each50580-317d288f27e-633e-4d97-8309-657a6f87df8b12015-12-02
50580-317-05EA - Each50580-31711ef38d7-d1d1-4b5f-b44f-c1ef541ed65412015-12-02
50580-317-06EA - Each50580-3176ffc1b8b-a2b5-486e-81e3-df797cf6e5e612020-04-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Loperamide hydrochlorideACTIVE INGREDIENT77TI35393CIMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
LoperamideACTIVE MOIETY6X9OC3H4IIIMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKIMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
carnauba waxINACTIVE INGREDIENTR12CBM0EIZIMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UIMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
hypromellosesINACTIVE INGREDIENT3NXW29V3WOIMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
magnesium stearateINACTIVE INGREDIENT70097M6I30IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AIMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-317IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [KENVUE BRANDS LLC]12Current NDC, Legacy NDC, 12 package rows20241109_01da76d0-1979-4c45-9d39-c72ae4e4ffe2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978013Imodium A-D 2 MG Oral TabletPSN01da76d0-1979-4c45-9d39-c72ae4e4ffe213
978010loperamide HCl 2 MG Oral TabletPSN01da76d0-1979-4c45-9d39-c72ae4e4ffe213
978013loperamide hydrochloride 2 MG Oral Tablet [Imodium]SBD01da76d0-1979-4c45-9d39-c72ae4e4ffe213
978010loperamide hydrochloride 2 MG Oral TabletSCD01da76d0-1979-4c45-9d39-c72ae4e4ffe213
978013Imodium 2 MG Oral TabletSY01da76d0-1979-4c45-9d39-c72ae4e4ffe213
978013Imodium A-D 2 MG Oral TabletSY01da76d0-1979-4c45-9d39-c72ae4e4ffe213

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-317-01505800317011 BLISTER PACK in 1 CARTON (50580-317-01) / 6 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2015-07-130000-00-00NoNoCurrent
50580-317-03505800317034 BLISTER PACK in 1 CARTON (50580-317-03) / 6 TABLET, FILM COATED in 1 BLISTER PACK4 blister pack2015-07-130000-00-00NoNoCurrent
50580-317-04505800317046 in 1 BLISTER PACKHistorical
50580-317-05505800317058 BLISTER PACK in 1 CARTON (50580-317-05) > 6 TABLET, FILM COATED in 1 BLISTER PACK8 blister pack2015-07-130000-00-00NoNoCurrent
50580-317-06505800317062 BLISTER PACK in 1 CARTON (50580-317-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2020-02-100000-00-00NoNoCurrent
50580-317-12505800317122 BLISTER PACK in 1 CARTON (50580-317-12) / 6 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2024-01-29NoNoCurrent