Loperamide Hydrochloride

Product NDC
55154-4699
11-digit product format
551544699
Labeler code
55154
Product ID
55154-4699_b02ac8e4-7fbf-47e0-945c-36ebc5928ccb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA073192
Marketing category
ANDA
Marketing start
2017-01-03
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-4699-0Loperamide Hydrochloride1 in 1 BLISTER PACKCAPSULE15
55154-4699-0Loperamide Hydrochloride10 in 1 BAGCAPSULE105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-4699LOPERAMIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH 107, LLC]4Current NDC, Legacy NDC, 2 package rows20240509_ca8de42f-8aea-4e35-ab3a-75ecea718f4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSNca8de42f-8aea-4e35-ab3a-75ecea718f4f5
978006loperamide hydrochloride 2 MG Oral CapsuleSCDca8de42f-8aea-4e35-ab3a-75ecea718f4f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-4699-05515446990010 BLISTER PACK in 1 BAG (55154-4699-0) / 1 CAPSULE in 1 BLISTER PACK10 blister pack2017-01-030000-00-00NoNoCurrent