FDA.reportPublic FDA data

Anti Diarrheal

Product NDC
83324-064
11-digit product format
833240064
Labeler code
83324
Product ID
83324-064_12b1101a-8ced-4441-84f9-39aa4ebc9587
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide HCl
Dosage form
TABLET
Route
ORAL
Labeler
Chain Drug Marketing Association, Inc.
Application
ANDA076497
Marketing category
ANDA
Marketing start
2024-06-17
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
Anti Diarrheal
Listing expiration
2027-12-31

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
83324-064-12Anti Diarrheal6 in 1 BLISTER PACKTABLET66
83324-064-12Anti Diarrheal2 in 1 CARTONTABLET26
83324-064-24Anti Diarrheal6 in 1 BLISTER PACKTABLET66
83324-064-24Anti Diarrheal4 in 1 CARTONTABLET46

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83324-064-12EA - Each83324-064cae27519-f346-4f93-8006-40883d7d9fa412026-01-08
83324-064-24EA - Each83324-064f26e425e-3535-495f-9163-911f5f14d7c312026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-064ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET [CHAIN DRUG MARKETING ASSOCIATION, INC.]5Current NDC, 4 package rows20250519_dd993f38-a31f-4739-9496-e14186a89053.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSNdd993f38-a31f-4739-9496-e14186a890536
978010loperamide hydrochloride 2 MG Oral TabletSCDdd993f38-a31f-4739-9496-e14186a890536

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83324-064-12833240064122 BLISTER PACK in 1 CARTON (83324-064-12) / 6 TABLET in 1 BLISTER PACK2 blister pack2024-06-17NoNoCurrent
83324-064-24833240064244 BLISTER PACK in 1 CARTON (83324-064-24) / 6 TABLET in 1 BLISTER PACK4 blister pack2024-06-17NoNoCurrent