FDA.reportPublic FDA data

Equate Loperamide Hydrochloride

Product NDC
49035-451
11-digit product format
490350451
Labeler code
49035
Product ID
49035-451_160fe0c3-cf1f-4317-b005-608923044668
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide HCl
Dosage form
SUSPENSION
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
ANDA091292
Marketing category
ANDA
Marketing start
2018-07-10
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
Equate Loperamide Hydrochloride
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
49035-451-26Equate Loperamide Hydrochloride118 mL in 1 BOTTLESUSPENSION1187
49035-451-34Equate Loperamide Hydrochloride240 mL in 1 BOTTLESUSPENSION2407

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-451-34ML - Milliliter49035-451608fa775-54cd-4880-818d-40b257f8495312024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-451EQUATE LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [WAL-MART STORES INC]6Current NDC, Legacy NDC, 2 package rows20241210_d8efaddf-4c28-4a7d-af58-42850c7901cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1250685loperamide HCl 1 MG in 7.5 mL Oral SuspensionPSNd8efaddf-4c28-4a7d-af58-42850c7901cd7
1250685loperamide hydrochloride 0.133 MG/ML Oral SuspensionSCDd8efaddf-4c28-4a7d-af58-42850c7901cd7
1250685loperamide HCl 1 MG per 7.5 ML Oral SolutionSYd8efaddf-4c28-4a7d-af58-42850c7901cd7
1250685loperamide hydrochloride 1 MG per 7.5 ML Oral SuspensionSYd8efaddf-4c28-4a7d-af58-42850c7901cd7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-451-2649035045126118 mL in 1 BOTTLE (49035-451-26) 118 ml2018-07-100000-00-00NoNoCurrent
49035-451-3449035045134240 mL in 1 BOTTLE (49035-451-34) 240 ml2019-06-120000-00-00NoNoCurrent