FDA.reportPublic FDA data

Loperamide Hydrochloride

Product NDC
15127-338
11-digit product format
151270338
Labeler code
15127
Product ID
15127-338_e887e062-0b65-4612-b0bf-ea04f01cdbdb
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Select Brand
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
15127-338-122020-01-31C16284748780-19d75b9d0-2e78-f424-e053-dadaa90a57ceDrug Facts
15127-338-662020-01-31C16284748780-19d75b9d0-2e78-f424-e053-dadaa90a57ceDrug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
15127-338-12EA - Each15127-338bf1bbe6a-9fb0-42a5-9f0f-014abfb3f6e212013-02-13
15127-338-66EA - Each15127-338dc5ac78e-6882-4d8d-ac3d-bd32add7d4c512013-02-13

DailyMed Socrata Ingredients#

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