FDA.reportPublic FDA data

LOPERAMIDE HYDROCHLORIDE

Product NDC
58602-727
11-digit product format
586020727
Labeler code
58602
Product ID
58602-727_f9a53a23-a8ea-4521-8f0b-1bc2a658ff68
Type
HUMAN OTC DRUG
Nonproprietary name
LOPERAMIDE HYDROCHLORIDE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA220372
Marketing category
ANDA
Marketing start
2025-12-29
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
LOPERAMIDE HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOPERAMIDE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii77TI35393C
Rxcui978006

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
58602-727-74LOPERAMIDE HYDROCHLORIDE1 in 1 CARTONCAPSULE, LIQUID FILLED11
58602-727-74LOPERAMIDE HYDROCHLORIDE6 in 1 BLISTER PACKCAPSULE, LIQUID FILLED61
58602-727-75LOPERAMIDE HYDROCHLORIDE2 in 1 CARTONCAPSULE, LIQUID FILLED21
58602-727-75LOPERAMIDE HYDROCHLORIDE6 in 1 BLISTER PACKCAPSULE, LIQUID FILLED61
58602-727-76LOPERAMIDE HYDROCHLORIDE4 in 1 CARTONCAPSULE, LIQUID FILLED41
58602-727-76LOPERAMIDE HYDROCHLORIDE6 in 1 BLISTER PACKCAPSULE, LIQUID FILLED61
58602-727-80LOPERAMIDE HYDROCHLORIDE3 in 1 CARTONCAPSULE, LIQUID FILLED31
58602-727-80LOPERAMIDE HYDROCHLORIDE6 in 1 BLISTER PACKCAPSULE, LIQUID FILLED61

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSNf9a53a23-a8ea-4521-8f0b-1bc2a658ff681
978006loperamide hydrochloride 2 MG Oral CapsuleSCDf9a53a23-a8ea-4521-8f0b-1bc2a658ff681

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58602-727-74586020727741 BLISTER PACK in 1 CARTON (58602-727-74) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2025-12-29NoNoCurrent
58602-727-75586020727752 BLISTER PACK in 1 CARTON (58602-727-75) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2025-12-29NoNoCurrent
58602-727-76586020727764 BLISTER PACK in 1 CARTON (58602-727-76) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK4 blister pack2025-12-29NoNoCurrent
58602-727-80586020727803 BLISTER PACK in 1 CARTON (58602-727-80) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK3 blister pack2025-12-29NoNoCurrent