loperamide hydrochloride

Product NDC
0363-0645
11-digit product format
003630645
Labeler code
0363
Product ID
0363-0645_8aac3f97-448c-4bb9-a62e-0690071a48de
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide HCl
Dosage form
SUSPENSION
Route
ORAL
Labeler
Walgreen Company
Application
ANDA091292
Marketing category
ANDA
Marketing start
2012-05-18
Marketing end
0000-00-00
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
1 mg/7.5mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0645-26ML - Milliliter0363-0645a86441e1-a20e-40ab-8e44-7ecadf6828e912013-03-03
0363-0645-34ML - Milliliter0363-064524d685a3-16c9-4d8e-acd2-5b6348d66ac812016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CLOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [WALGREEN COMPANY]4
LOPERAMIDEACTIVE MOIETY6X9OC3H4IILOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [WALGREEN COMPANY]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLLOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [WALGREEN COMPANY]4
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [WALGREEN COMPANY]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [WALGREEN COMPANY]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [WALGREEN COMPANY]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [WALGREEN COMPANY]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [WALGREEN COMPANY]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [WALGREEN COMPANY]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EULOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [WALGREEN COMPANY]4
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [WALGREEN COMPANY]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [WALGREEN COMPANY]4
WATERINACTIVE INGREDIENT059QF0KO0RLOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [WALGREEN COMPANY]4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEELOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [WALGREEN COMPANY]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0645LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [WALGREEN COMPANY]5Legacy NDC20180123_65abebcc-f5e2-4bd5-bf37-20e0fb53dc4c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0645-2600363064526120 mL in 1 BOTTLE (0363-0645-26) 120 ml2012-05-180000-00-00NoNoCurrent
0363-0645-3400363064534240 mL in 1 BOTTLE (0363-0645-34) 240 ml2012-05-180000-00-00NoNoCurrent