anti-diarrheal

Product NDC
63941-684
11-digit product format
639410684
Labeler code
63941
Product ID
63941-684_06fe77f7-a20c-f066-e063-6294a90a7653
Type
HUMAN OTC DRUG
Nonproprietary name
LOPERAMIDE HYDROCHLORIDE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
VALU MERCHANDISERS COMPANY
Application
NDA021855
Marketing category
NDA
Marketing start
2023-10-10
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
anti-diarrheal
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
63941-684-12anti-diarrheal2 in 1 CARTONCAPSULE, LIQUID FILLED22
63941-684-12anti-diarrheal12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-684ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [VALU MERCHANDISERS COMPANY]2Current NDC, 2 package rows20231011_fed347ad-cfbb-9ee8-e053-6394a90ad275.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSNfed347ad-cfbb-9ee8-e053-6394a90ad2752
978006loperamide hydrochloride 2 MG Oral CapsuleSCDfed347ad-cfbb-9ee8-e053-6394a90ad2752

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63941-684-12639410684122 BLISTER PACK in 1 CARTON (63941-684-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2023-10-10NoNoHistorical