good neighbor pharmacy loperamide hydrochloride

Product NDC
46122-544
11-digit product format
461220544
Labeler code
46122
Product ID
46122-544_a5d954e8-f982-4e56-8f77-6baeddc2124e
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Amerisource Bergen
Application
ANDA091292
Marketing category
ANDA
Marketing start
2018-08-13
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
good neighbor pharmacy 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
46122-544-26good neighbor pharmacy loperamide hydrochloride120 mL in 1 BOTTLESOLUTION1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-544GOOD NEIGHBOR PHARMACY LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SOLUTION [AMERISOURCE BERGEN]3Current NDC, Legacy NDC, 1 package rows20250416_53f66b4a-b97b-4995-b2cf-e33afe996af1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1250685loperamide HCl 1 MG in 7.5 mL Oral SuspensionPSN53f66b4a-b97b-4995-b2cf-e33afe996af13
1250685loperamide hydrochloride 0.133 MG/ML Oral SuspensionSCD53f66b4a-b97b-4995-b2cf-e33afe996af13
1250685loperamide HCl 1 MG per 7.5 ML Oral SolutionSY53f66b4a-b97b-4995-b2cf-e33afe996af13
1250685loperamide hydrochloride 1 MG per 7.5 ML Oral SuspensionSY53f66b4a-b97b-4995-b2cf-e33afe996af13
1250685loperamide HCl 1 MG in 7.5 mL Oral SuspensionPSNc923b712-e269-4270-bba7-972010febe832
1250685loperamide hydrochloride 0.133 MG/ML Oral SuspensionSCDc923b712-e269-4270-bba7-972010febe832
1250685loperamide HCl 1 MG per 7.5 ML Oral SolutionSYc923b712-e269-4270-bba7-972010febe832
1250685loperamide hydrochloride 1 MG per 7.5 ML Oral SuspensionSYc923b712-e269-4270-bba7-972010febe832

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46122-544-2646122054426120 mL in 1 BOTTLE (46122-544-26) 120 ml2018-08-130000-00-00NoNoCurrent