Leader Anti Diarrheal

Product NDC
70000-0225
11-digit product format
700000225
Labeler code
70000
Product ID
70000-0225_dd0ee798-d323-4d39-a04c-d2e10df1cd2f
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 110, LLC. dba Leader
Application
ANDA075232
Marketing category
ANDA
Marketing start
2017-01-17
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
2 mg/1
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 HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii77TI35393C
Rxcui978010

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
70000-0225-1Leader Anti Diarrheal24 in 1 CARTONTABLET, FILM COATED245
70000-0225-1Leader Anti Diarrheal1 in 1 BLISTER PACKTABLET, FILM COATED15
70000-0225-2Leader Anti Diarrheal12 in 1 CARTONTABLET, FILM COATED125
70000-0225-2Leader Anti Diarrheal1 in 1 BLISTER PACKTABLET, FILM COATED15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0225-2EA - Each70000-02256b98fb07-ba91-411a-af39-6b63a3aade3412020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0225LEADER ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [CARDINAL HEALTH 110, LLC. DBA LEADER]4Current NDC, Legacy NDC, 4 package rows20210620_9079a59b-a158-4e77-a104-547959f7ba78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSN9079a59b-a158-4e77-a104-547959f7ba785
978010loperamide hydrochloride 2 MG Oral TabletSCD9079a59b-a158-4e77-a104-547959f7ba785

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0225-17000002250124 BLISTER PACK in 1 CARTON (70000-0225-1) > 1 TABLET, FILM COATED in 1 BLISTER PACK24 blister pack2017-01-170000-00-00NoNoCurrent
70000-0225-27000002250212 BLISTER PACK in 1 CARTON (70000-0225-2) / 1 TABLET, FILM COATED in 1 BLISTER PACK12 blister pack2020-02-020000-00-00NoNoCurrent