Loperamide Hydrochloride

Product NDC
46122-169
11-digit product format
461220169
Labeler code
46122
Product ID
46122-169_80a4c80a-d34f-48d8-8484-f605ad892a25
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Amerisource Bergen
Application
ANDA074091
Marketing category
ANDA
Marketing start
1993-02-01
Marketing end
0000-00-00
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
2 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
10f838ef-a72b-645d-80f8-e2255205c3b1Product name620240805

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46122-169-082020-01-31C16284748780-19d75b9d0-eb63-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-169-08Loperamide Hydrochloride72 in 1 BOTTLETABLET721

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-169-08EA - Each46122-16931b2cb1b-1d82-47bb-8aad-f2275301df7f12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CLOPERAMIDE HYDROCHLORIDE TABLET [AMERISOURCE BERGEN]1
LOPERAMIDEACTIVE MOIETY6X9OC3H4IILOPERAMIDE HYDROCHLORIDE TABLET [AMERISOURCE BERGEN]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLOPERAMIDE HYDROCHLORIDE TABLET [AMERISOURCE BERGEN]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LOPERAMIDE HYDROCHLORIDE TABLET [AMERISOURCE BERGEN]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLOPERAMIDE HYDROCHLORIDE TABLET [AMERISOURCE BERGEN]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLOPERAMIDE HYDROCHLORIDE TABLET [AMERISOURCE BERGEN]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLOPERAMIDE HYDROCHLORIDE TABLET [AMERISOURCE BERGEN]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOPERAMIDE HYDROCHLORIDE TABLET [AMERISOURCE BERGEN]1
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MLOPERAMIDE HYDROCHLORIDE TABLET [AMERISOURCE BERGEN]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJLOPERAMIDE HYDROCHLORIDE TABLET [AMERISOURCE BERGEN]1
TRISTEARININACTIVE INGREDIENTP6OCJ2551RLOPERAMIDE HYDROCHLORIDE TABLET [AMERISOURCE BERGEN]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-169LOPERAMIDE HYDROCHLORIDE TABLET [AMERISOURCE BERGEN]1Legacy NDC, 1 package rows20121121_cb8de80f-8a28-4eb1-a431-01ff8f32d756.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSNcb8de80f-8a28-4eb1-a431-01ff8f32d7561
978010loperamide hydrochloride 2 MG Oral TabletSCDcb8de80f-8a28-4eb1-a431-01ff8f32d7561

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
46122-169-084612201690872 in 1 BOTTLEHistorical