leader anti diarrheal

Product NDC
70000-0418
11-digit product format
700000418
Labeler code
70000
Product ID
70000-0418_9172bc2f-a9c3-4b2d-9f88-ea9f94491063
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide HCl
Dosage form
SUSPENSION
Route
ORAL
Labeler
Cardinal Health 110, LLC. dba Leader
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
leader 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
70000-0418-1leader anti diarrheal120 mL in 1 BOTTLESUSPENSION1204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0418-1ML - Milliliter70000-04185182fb9d-c94d-4fae-b328-19a7e6c278e312019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0418LEADER ANTI DIARRHEAL (LOPERAMIDE HCL) SUSPENSION [CARDINAL HEALTH 110, LLC. DBA LEADER]3Current NDC, Legacy NDC, 1 package rows20210618_f845fad8-6b3c-4c7e-94bc-d4f99f69e4f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1250685loperamide HCl 1 MG in 7.5 mL Oral SuspensionPSNf845fad8-6b3c-4c7e-94bc-d4f99f69e4f04
1250685loperamide hydrochloride 0.133 MG/ML Oral SuspensionSCDf845fad8-6b3c-4c7e-94bc-d4f99f69e4f04
1250685loperamide HCl 1 MG per 7.5 ML Oral SolutionSYf845fad8-6b3c-4c7e-94bc-d4f99f69e4f04
1250685loperamide hydrochloride 1 MG per 7.5 ML Oral SuspensionSYf845fad8-6b3c-4c7e-94bc-d4f99f69e4f04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0418-170000041801120 mL in 1 BOTTLE (70000-0418-1) 120 ml2018-08-130000-00-00NoNoCurrent