Good Sense antidiarrheal

Product NDC
68788-8796
11-digit product format
687888796
Labeler code
68788
Product ID
68788-8796_629a5cda-43d5-433d-bbdc-4d90a5c0f02a
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA091292
Marketing category
ANDA
Marketing start
2025-01-01
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
1 mg/7.5mL
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Good Sense antidiarrheal
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOPERAMIDE HYDROCHLORIDE1 mg/7.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii77TI35393C
Rxcui1250685

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
68788-8796-1Good Sense antidiarrheal120 mL in 1 BOTTLESOLUTION1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8796-1ML - Milliliter68788-8796196072ca-b25c-44d8-998e-e363a32fb07c12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8796GOOD SENSE ANTIDIARRHEAL (LOPERAMIDE HCL) SOLUTION [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 1 package rows20250101_672ca656-6abb-42d4-8dbc-9f3428c35058.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1250685loperamide HCl 1 MG in 7.5 mL Oral SuspensionPSN672ca656-6abb-42d4-8dbc-9f3428c350582
1250685loperamide hydrochloride 0.133 MG/ML Oral SuspensionSCD672ca656-6abb-42d4-8dbc-9f3428c350582
1250685loperamide HCl 1 MG per 7.5 ML Oral SolutionSY672ca656-6abb-42d4-8dbc-9f3428c350582
1250685loperamide hydrochloride 1 MG per 7.5 ML Oral SuspensionSY672ca656-6abb-42d4-8dbc-9f3428c350582

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8796-168788879601120 mL in 1 BOTTLE (68788-8796-1) 120 ml2025-01-01NoNoHistorical