FDA.reportPublic FDA data

Loperamide Hydrochloride

Product NDC
68016-123
11-digit product format
680160123
Labeler code
68016
Product ID
68016-123_0ea714a1-b048-bc87-e063-6294a90a28e7
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Chain Drug Consortium, LLC
Application
ANDA074091
Marketing category
ANDA
Marketing start
1993-02-01
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Loperamide Hydrochloride
Listing expiration
2026-12-31

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
68016-123-06Loperamide Hydrochloride6 in 1 BLISTER PACKTABLET66
68016-123-18Loperamide Hydrochloride18 in 1 BLISTER PACKTABLET186
68016-123-24Loperamide Hydrochloride24 in 1 BLISTER PACKTABLET246
68016-123-97Loperamide Hydrochloride96 in 1 BOTTLETABLET966

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-123-06EA - Each68016-123ebe4dab6-9c8d-4b8f-8170-3c25f71d0b7c12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CLOPERAMIDE HYDROCHLORIDE TABLET [CHAIN DRUG CONSORTIUM, LLC]3
LOPERAMIDEACTIVE MOIETY6X9OC3H4IILOPERAMIDE HYDROCHLORIDE TABLET [CHAIN DRUG CONSORTIUM, LLC]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLOPERAMIDE HYDROCHLORIDE TABLET [CHAIN DRUG CONSORTIUM, LLC]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LOPERAMIDE HYDROCHLORIDE TABLET [CHAIN DRUG CONSORTIUM, LLC]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLOPERAMIDE HYDROCHLORIDE TABLET [CHAIN DRUG CONSORTIUM, LLC]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLOPERAMIDE HYDROCHLORIDE TABLET [CHAIN DRUG CONSORTIUM, LLC]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLOPERAMIDE HYDROCHLORIDE TABLET [CHAIN DRUG CONSORTIUM, LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOPERAMIDE HYDROCHLORIDE TABLET [CHAIN DRUG CONSORTIUM, LLC]3
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MLOPERAMIDE HYDROCHLORIDE TABLET [CHAIN DRUG CONSORTIUM, LLC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOPERAMIDE HYDROCHLORIDE TABLET [CHAIN DRUG CONSORTIUM, LLC]3
TRISTEARININACTIVE INGREDIENTP6OCJ2551RLOPERAMIDE HYDROCHLORIDE TABLET [CHAIN DRUG CONSORTIUM, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-123LOPERAMIDE HYDROCHLORIDE TABLET [CHAIN DRUG CONSORTIUM, LLC]6Current NDC, Legacy NDC, 4 package rows20240112_b070896b-1e22-41d4-a66d-8d3be1699217.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSNb070896b-1e22-41d4-a66d-8d3be16992176
978010loperamide hydrochloride 2 MG Oral TabletSCDb070896b-1e22-41d4-a66d-8d3be16992176

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-123-06680160123066 TABLET in 1 BLISTER PACK (68016-123-06) 6 tablet1993-02-010000-00-00NoNoCurrent
68016-123-186801601231818 TABLET in 1 BLISTER PACK (68016-123-18) 18 tablet1993-02-010000-00-00NoNoCurrent
68016-123-246801601232424 TABLET in 1 BLISTER PACK (68016-123-24) 24 tablet1993-02-010000-00-00NoNoCurrent
68016-123-976801601239796 TABLET in 1 BOTTLE (68016-123-97) 96 tablet1993-02-010000-00-00NoNoCurrent