WELMATE Anti Diarrheal Loperamide HCl Softgels

Product NDC
73581-102
11-digit product format
735810102
Labeler code
73581
Product ID
73581-102_ec6b87f1-e600-21c2-e053-2a95a90ab76d
Type
HUMAN OTC DRUG
Nonproprietary name
LOPERAMIDE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
YYBA CORP
Application
NDA021855
Marketing category
NDA
Marketing start
2020-08-22
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
WELMATE Anti Diarrheal Loperamide HCl Softgels
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
73581-102-24WELMATE Anti Diarrheal Loperamide HCl Softgels12 in 1 BLISTER PACKCAPSULE123
73581-102-24WELMATE Anti Diarrheal Loperamide HCl Softgels2 in 1 CARTONCAPSULE23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73581-102WELMATE ANTI DIARRHEAL LOPERAMIDE HCL SOFTGELS (LOPERAMIDE HYDROCHLORIDE) CAPSULE [YYBA CORP]3Current NDC, Legacy NDC, 2 package rows20221102_ae2e15e9-1707-296d-e053-2995a90a1b95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSNae2e15e9-1707-296d-e053-2995a90a1b953
978006loperamide hydrochloride 2 MG Oral CapsuleSCDae2e15e9-1707-296d-e053-2995a90a1b953

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73581-102-24735810102242 BLISTER PACK in 1 CARTON (73581-102-24) / 12 CAPSULE in 1 BLISTER PACK2 blister pack2020-08-220000-00-00NoNoCurrent