loperamide hydrochloride

Product NDC
11822-1645
11-digit product format
118221645
Labeler code
11822
Product ID
11822-1645_18471e7d-1097-45b9-b9a9-54786fe6097f
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide HCl
Dosage form
SUSPENSION
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA091292
Marketing category
ANDA
Marketing start
2012-05-23
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 Product Concepts#

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

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-1645LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SUSPENSION [RITE AID CORPORATION]5Legacy NDC20180123_efb4ab17-7a75-4e1a-9078-457af14c473a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-1645-111822164501120 mL in 1 BOTTLE (11822-1645-1) 120 ml2012-05-230000-00-00NoNoCurrent
11822-1645-211822164502240 mL in 1 BOTTLE (11822-1645-2) 240 ml2012-05-230000-00-00NoNoCurrent