Anti Diarrheal

Product NDC
55301-375
11-digit product format
553010375
Labeler code
55301
Product ID
55301-375_2a67c0b9-148e-4f64-94d4-1e502a47b382
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide HCl
Dosage form
TABLET
Route
ORAL
Labeler
ARMY AND AIR FORCE EXCHANGE SERVICE
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
2027-12-31

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
55301-375-02Anti Diarrheal6 in 1 BLISTER PACKTABLET621
55301-375-02Anti Diarrheal2 in 1 CARTONTABLET221

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CANTI DIARRHEAL (LOPERAMIDE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]3
LOPERAMIDEACTIVE MOIETY6X9OC3H4IIANTI DIARRHEAL (LOPERAMIDE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UANTI DIARRHEAL (LOPERAMIDE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-375ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]19Current NDC, Legacy NDC, 2 package rows20241127_f93a1f1f-2233-4338-9643-1ba48bd000bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSNf93a1f1f-2233-4338-9643-1ba48bd000bc21
978010loperamide hydrochloride 2 MG Oral TabletSCDf93a1f1f-2233-4338-9643-1ba48bd000bc21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55301-375-02553010375022 BLISTER PACK in 1 CARTON (55301-375-02) / 6 TABLET in 1 BLISTER PACK2 blister pack2005-05-030000-00-00NoNoCurrent