FDA.reportPublic FDA data

Loperamide Hydrochloride

Product NDC
50268-482
11-digit product format
502680482
Labeler code
50268
Product ID
50268-482_2b49645c-34d1-c6ab-e063-6394a90aaee5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
loperamide hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
AvPAK
Application
ANDA215579
Marketing category
ANDA
Marketing start
2023-04-05
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
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
50268-482-11Loperamide Hydrochloride1 in 1 BLISTER PACKCAPSULE12
50268-482-15Loperamide Hydrochloride50 in 1 BOXCAPSULE502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-482-11EA - Each50268-482f389e199-aa94-46dc-983f-b9513fa21af112023-05-05
50268-482-15EA - Each50268-48280c40dc5-f369-4c34-a27d-d7264a12d6aa12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-482LOPERAMIDE HYDROCHLORIDE CAPSULE [AVPAK]2Current NDC, 2 package rows20250112_f8992723-dd9a-bcf6-e053-6294a90aa65c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSNf8992723-dd9a-bcf6-e053-6294a90aa65c2
978006loperamide hydrochloride 2 MG Oral CapsuleSCDf8992723-dd9a-bcf6-e053-6294a90aa65c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50268-482-11502680482111 in 1 BLISTER PACKHistorical
50268-482-155026804821550 BLISTER PACK in 1 BOX (50268-482-15) / 1 CAPSULE in 1 BLISTER PACK (50268-482-11) 50 blister pack2023-04-05NoNoCurrent