FDA.reportPublic FDA data

Loperamide Hydrochloride

Product NDC
58602-701
11-digit product format
586020701
Labeler code
58602
Product ID
58602-701_1645400c-43fb-4b64-98bc-33f85ce827f7
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA206548
Marketing category
ANDA
Marketing start
2015-12-15
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
Loperamide Hydrochloride
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
58602-701-01Loperamide Hydrochloride1 in 1 CARTONTABLET110
58602-701-01Loperamide Hydrochloride6 in 1 BLISTER PACKTABLET610
58602-701-02Loperamide Hydrochloride6 in 1 BLISTER PACKTABLET610
58602-701-02Loperamide Hydrochloride2 in 1 CARTONTABLET210
58602-701-76Loperamide Hydrochloride6 in 1 BLISTER PACKTABLET610
58602-701-76Loperamide Hydrochloride4 in 1 CARTONTABLET410

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58602-701-76EA - Each58602-7013fe5611c-0ec0-4130-8a49-808f280033da12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-701LOPERAMIDE HYDROCHLORIDE TABLET [AUROHEALTH LLC]10Current NDC, Legacy NDC, 6 package rows20250123_f3ea8779-252e-4038-ae41-500e15c54825.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSNf3ea8779-252e-4038-ae41-500e15c5482510
978010loperamide hydrochloride 2 MG Oral TabletSCDf3ea8779-252e-4038-ae41-500e15c5482510
978010loperamide HCl 2 MG Oral TabletPSN5b173bb9-3cca-44ce-9bcb-b9ecc93d3dcf5
978010loperamide hydrochloride 2 MG Oral TabletSCD5b173bb9-3cca-44ce-9bcb-b9ecc93d3dcf5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-701-01586020701011 BLISTER PACK in 1 CARTON (58602-701-01) / 6 TABLET in 1 BLISTER PACK1 blister pack2015-12-150000-00-00NoNoCurrent
58602-701-02586020701022 BLISTER PACK in 1 CARTON (58602-701-02) / 6 TABLET in 1 BLISTER PACK2 blister pack2015-12-150000-00-00NoNoCurrent
58602-701-76586020701764 BLISTER PACK in 1 CARTON (58602-701-76) / 6 TABLET in 1 BLISTER PACK4 blister pack2015-12-150000-00-00NoNoCurrent