FDA.reportPublic FDA data

LOPERAMIDE HYDROCHLORIDE

Product NDC
58602-727
11-digit product format
586020727
Labeler code
58602
Product ID
58602-727_fe72649e-b4ec-4aaa-9a99-b81104a37710
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A220372-001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2025-12-29

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A220372-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2025-12-2984e616aacf4f…
2026-08-18 06:07:402026-07A220372-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2025-12-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A220372-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2025-12-29011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220372-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2025-12-29a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
77TI35393CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
978006Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f9a53a23-a8ea-4521-8f0b-1bc2a658ff68Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDEYYBA CORP5a728c6d-26ec-3316-e063-6394a90ade082026-09-09WarningsExact identifier
application applno (ANDA): 220372
application number: ANDA220372
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDEAurohealth LLCf9a53a23-a8ea-4521-8f0b-1bc2a658ff682026-08-28WarningsExact identifier
application applno (ANDA): 220372
application number: ANDA220372
ndc (product): 58602-727

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
58602-727-77586020727771 BLISTER PACK in 1 CARTON (58602-727-77) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2026-08-28NoNoCurrent
58602-727-78586020727782 BLISTER PACK in 1 CARTON (58602-727-78) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2026-08-28NoNoCurrent
58602-727-80586020727803 BLISTER PACK in 1 CARTON (58602-727-80) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK3 blister pack2025-12-29NoNoCurrent