Loperamide Hydrochloride

Product NDC
37808-645
11-digit product format
378080645
Labeler code
37808
Product ID
37808-645_1790afa2-8e6f-4f4d-b63e-81fd4706f05d
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide HCl
Dosage form
SUSPENSION
Route
ORAL
Labeler
H E B
Application
ANDA091292
Marketing category
ANDA
Marketing start
2012-03-05
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 Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-645LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [H E B]5Legacy NDC20180123_82b4ecac-7725-48e2-9cc2-ba856ed70d2e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-645-2637808064526120 mL in 1 BOTTLE (37808-645-26) 120 ml2012-03-050000-00-00NoNoCurrent
37808-645-3437808064534240 mL in 1 BOTTLE (37808-645-34) 240 ml2012-03-050000-00-00NoNoCurrent