basic care loperamide hydrochloride

Product NDC
72288-645
11-digit product format
722880645
Labeler code
72288
Product ID
72288-645_8848c443-23c1-419f-af81-58beb92fc74a
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA091292
Marketing category
ANDA
Marketing start
2021-01-21
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
basic care 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
72288-645-34basic care loperamide hydrochloride240 mL in 1 BOTTLESOLUTION2403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-645BASIC CARE LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SOLUTION [AMAZON.COM SERVICES LLC]3Current NDC, Legacy NDC, 1 package rows20250406_d6b8015c-f8fe-45cb-891f-566fb319b46b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1250685loperamide HCl 1 MG in 7.5 mL Oral SuspensionPSNd6b8015c-f8fe-45cb-891f-566fb319b46b3
1250685loperamide hydrochloride 0.133 MG/ML Oral SuspensionSCDd6b8015c-f8fe-45cb-891f-566fb319b46b3
1250685loperamide HCl 1 MG per 7.5 ML Oral SolutionSYd6b8015c-f8fe-45cb-891f-566fb319b46b3
1250685loperamide hydrochloride 1 MG per 7.5 ML Oral SuspensionSYd6b8015c-f8fe-45cb-891f-566fb319b46b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-645-3472288064534240 mL in 1 BOTTLE (72288-645-34) 240 ml2021-01-210000-00-00NoNoCurrent