Anti Diarrheal

Product NDC
67091-405
11-digit product format
670910405
Labeler code
67091
Product ID
67091-405_1d21dc63-1ef4-4d5b-b7e3-a861b0e0855c
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide HCL
Dosage form
CAPSULE
Route
ORAL
Labeler
WinCo Foods
Application
ANDA076497
Marketing category
ANDA
Marketing start
2022-03-01
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

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
67091-405-12Anti Diarrheal12 in 1 BLISTER PACKCAPSULE122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-405ANTI DIARRHEAL (LOPERAMIDE HCL) CAPSULE [WINCO FOODS]2Current NDC, Legacy NDC, 1 package rows20220301_3ec4c6c7-c297-4ae4-b275-4c015e922bec.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67091-405-126709104051212 CAPSULE in 1 BLISTER PACK (67091-405-12) 12 capsule2022-03-010000-00-00NoNoCurrent