Imodium A-D

Product NDC
50580-367
11-digit product format
505800367
Labeler code
50580
Product ID
50580-367_460d0a84-5c0c-b974-e063-6294a90ab761
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Kenvue Brands LLC
Application
NDA021855
Marketing category
NDA
Marketing start
2016-07-11
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 A-D
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOPERAMIDE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii77TI35393C
Rxcui978006, 978009

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
50580-367-01Imodium A-D1 in 1 CARTONCAPSULE, LIQUID FILLED110
50580-367-01Imodium A-D12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1210
50580-367-02Imodium A-D12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1210
50580-367-02Imodium A-D2 in 1 CARTONCAPSULE, LIQUID FILLED210

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-367-01EA - Each50580-3677fb643da-a81a-4130-9c1c-65c3a40deecd12019-05-02
50580-367-02EA - Each50580-36792d6ba5b-5582-4f90-9293-f54a53fade4512017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-367IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [KENVUE BRANDS LLC]9Current NDC, Legacy NDC, 4 package rows20241109_31bfcbb4-c58c-4edc-ac68-356a448b7507.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978009Imodium 2 MG Oral CapsulePSN31bfcbb4-c58c-4edc-ac68-356a448b750710
978006loperamide HCl 2 MG Oral CapsulePSN31bfcbb4-c58c-4edc-ac68-356a448b750710
978009loperamide hydrochloride 2 MG Oral Capsule [Imodium]SBD31bfcbb4-c58c-4edc-ac68-356a448b750710
978006loperamide hydrochloride 2 MG Oral CapsuleSCD31bfcbb4-c58c-4edc-ac68-356a448b750710
978009Imodium 2 MG Oral CapsuleSY31bfcbb4-c58c-4edc-ac68-356a448b750710

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-367-01505800367011 BLISTER PACK in 1 CARTON (50580-367-01) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2016-07-110000-00-00NoNoCurrent
50580-367-02505800367022 BLISTER PACK in 1 CARTON (50580-367-02) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2016-07-110000-00-00NoNoCurrent