leader anti diarrheal

Product NDC
70000-0417
11-digit product format
700000417
Labeler code
70000
Product ID
70000-0417_0e8c379f-d704-46b4-8297-fb995e0171ec
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Cardinal Health 110, LLC. dba Leader
Application
ANDA091292
Marketing category
ANDA
Marketing start
2018-07-16
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
70000-0417-1leader anti diarrheal120 mL in 1 BOTTLESOLUTION1204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0417-1ML - Milliliter70000-041774fc37fb-6877-40a5-a87f-958e171506b412019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0417LEADER ANTI DIARRHEAL (LOPERAMIDE HCL) SOLUTION [CARDINAL HEALTH 110, LLC. DBA LEADER]4Current NDC, Legacy NDC, 1 package rows20250416_c27e6fbd-8822-4784-9d24-497ae78e54f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1250685loperamide HCl 1 MG in 7.5 mL Oral SuspensionPSNc27e6fbd-8822-4784-9d24-497ae78e54f44
1250685loperamide hydrochloride 0.133 MG/ML Oral SuspensionSCDc27e6fbd-8822-4784-9d24-497ae78e54f44
1250685loperamide HCl 1 MG per 7.5 ML Oral SolutionSYc27e6fbd-8822-4784-9d24-497ae78e54f44
1250685loperamide hydrochloride 1 MG per 7.5 ML Oral SuspensionSYc27e6fbd-8822-4784-9d24-497ae78e54f44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0417-170000041701120 mL in 1 BOTTLE (70000-0417-1) 120 ml2018-07-160000-00-00NoNoCurrent