Anti-Diarrheal

Product NDC
69168-248
11-digit product format
691680248
Labeler code
69168
Product ID
69168-248_ef9b20dc-0119-49c1-bc31-2c9fc1f4d772
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Allegiant Health
Application
ANDA076497
Marketing category
ANDA
Marketing start
2005-05-03
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
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
69168-248-86Anti-Diarrheal6 in 1 BLISTER PACKTABLET, COATED65
69168-248-86Anti-Diarrheal2 in 1 CARTONTABLET, COATED25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-248ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET, COATED [ALLEGIANT HEALTH]5Current NDC, Legacy NDC, 2 package rows20210923_aca3742c-2a82-4e91-8aaf-2fce08487e56.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSNaca3742c-2a82-4e91-8aaf-2fce08487e565
978010loperamide hydrochloride 2 MG Oral TabletSCDaca3742c-2a82-4e91-8aaf-2fce08487e565

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69168-248-86691680248862 BLISTER PACK in 1 CARTON (69168-248-86) / 6 TABLET, COATED in 1 BLISTER PACK2 blister pack2005-05-030000-00-00NoNoCurrent