equaline loperamide hydrochloride

Product NDC
41163-210
11-digit product format
411630210
Labeler code
41163
Product ID
41163-210_f973597f-df96-4cc9-8a94-f4335efe6d3e
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
ANDA091292
Marketing category
ANDA
Marketing start
2018-05-21
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
equaline loperamide hydrochloride
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
41163-210-26equaline loperamide hydrochloride120 mL in 1 BOTTLESOLUTION1204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-210EQUALINE LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SOLUTION [UNITED NATURAL FOODS, INC. DBA UNFI]4Current NDC, Legacy NDC, 1 package rows20250416_9277f433-8b50-4b5b-bfe6-d257d89ebd90.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1250685loperamide HCl 1 MG in 7.5 mL Oral SuspensionPSN9277f433-8b50-4b5b-bfe6-d257d89ebd904
1250685loperamide hydrochloride 0.133 MG/ML Oral SuspensionSCD9277f433-8b50-4b5b-bfe6-d257d89ebd904
1250685loperamide HCl 1 MG per 7.5 ML Oral SolutionSY9277f433-8b50-4b5b-bfe6-d257d89ebd904
1250685loperamide hydrochloride 1 MG per 7.5 ML Oral SuspensionSY9277f433-8b50-4b5b-bfe6-d257d89ebd904

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-210-2641163021026120 mL in 1 BOTTLE (41163-210-26) 120 ml2018-05-210000-00-00NoNoCurrent