Anti-Diarrheal

Product NDC
11822-0375
11-digit product format
118220375
Labeler code
11822
Product ID
11822-0375_6e4a0f4e-4add-47b0-bb46-e1e120a608ec
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide HCl
Dosage form
TABLET
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA076497
Marketing category
ANDA
Marketing start
2005-05-03
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Anti-Diarrheal
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOPERAMIDE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii77TI35393C
Rxcui978010

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-0375-3Anti-Diarrheal6 in 1 BLISTER PACKTABLET628
11822-0375-3Anti-Diarrheal2 in 1 CARTONTABLET228
11822-0375-5Anti-Diarrheal1 in 1 CARTONTABLET128
11822-0375-5Anti-Diarrheal2 in 1 BLISTER PACKTABLET228
11822-0375-8Anti-Diarrheal6 in 1 BLISTER PACKTABLET628
11822-0375-8Anti-Diarrheal4 in 1 CARTONTABLET428

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [RITE AID]9
LOPERAMIDEACTIVE MOIETY6X9OC3H4IIANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [RITE AID]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [RITE AID]9
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [RITE AID]9
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [RITE AID]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [RITE AID]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0375ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [RITE AID CORPORATION]27Current NDC, Legacy NDC, 6 package rows20250331_c6cc4ba7-0e7a-4dd6-a5cf-b7e16e1a6c75.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSNc6cc4ba7-0e7a-4dd6-a5cf-b7e16e1a6c7528
978010loperamide hydrochloride 2 MG Oral TabletSCDc6cc4ba7-0e7a-4dd6-a5cf-b7e16e1a6c7528

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0375-3118220375032 BLISTER PACK in 1 CARTON (11822-0375-3) / 6 TABLET in 1 BLISTER PACK2 blister pack2005-05-030000-00-00NoNoCurrent
11822-0375-5118220375051 BLISTER PACK in 1 CARTON (11822-0375-5) > 2 TABLET in 1 BLISTER PACK1 blister pack2005-05-032021-07-15NoNoCurrent
11822-0375-8118220375084 BLISTER PACK in 1 CARTON (11822-0375-8) / 6 TABLET in 1 BLISTER PACK4 blister pack2005-05-030000-00-00NoNoCurrent