Anti Diarrheal

Product NDC
0363-2022
11-digit product format
003632022
Labeler code
0363
Product ID
0363-2022_c728470a-d949-43c1-9f56-9cf6706fd4c8
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Walgreen Company
Application
ANDA091292
Marketing category
ANDA
Marketing start
2022-03-21
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
1 mg/7.5mL
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 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
0363-2022-26Anti Diarrheal120 mL in 1 BOTTLESOLUTION1203
0363-2022-34Anti Diarrheal240 mL in 1 BOTTLESOLUTION2403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-2022ANTI DIARRHEAL (LOPERAMIDE HCL) SOLUTION [WALGREEN COMPANY]3Current NDC, Legacy NDC, 2 package rows20250416_f70d0568-27c0-4c63-8d68-82e31b87174f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1250685loperamide HCl 1 MG in 7.5 mL Oral SuspensionPSNf70d0568-27c0-4c63-8d68-82e31b87174f3
1250685loperamide hydrochloride 0.133 MG/ML Oral SuspensionSCDf70d0568-27c0-4c63-8d68-82e31b87174f3
1250685loperamide HCl 1 MG per 7.5 ML Oral SolutionSYf70d0568-27c0-4c63-8d68-82e31b87174f3
1250685loperamide hydrochloride 1 MG per 7.5 ML Oral SuspensionSYf70d0568-27c0-4c63-8d68-82e31b87174f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-2022-2600363202226120 mL in 1 BOTTLE (0363-2022-26) 120 ml2022-03-210000-00-00NoNoCurrent
0363-2022-3400363202234240 mL in 1 BOTTLE (0363-2022-34) 240 ml2022-03-210000-00-00NoNoCurrent