injoy diarrhea relief

Product NDC
0113-6004
11-digit product format
001136004
Labeler code
0113
Product ID
0113-6004_1a7df844-dca9-44aa-ae79-c35d07057b31
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA075232
Marketing category
ANDA
Marketing start
2022-08-09
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
injoy diarrhea relief
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
0113-6004-62injoy diarrhea relief1 in 1 BLISTER PACKTABLET, FILM COATED12
0113-6004-62injoy diarrhea relief24 in 1 CARTONTABLET, FILM COATED242

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-6004INJOY DIARRHEA RELIEF (LOPERAMIDE HCL) TABLET, FILM COATED [L. PERRIGO COMPANY]2Current NDC, Legacy NDC, 2 package rows20240816_cf5ccdf8-ab27-429f-a1b4-c51ced021046.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSNcf5ccdf8-ab27-429f-a1b4-c51ced0210462
978010loperamide hydrochloride 2 MG Oral TabletSCDcf5ccdf8-ab27-429f-a1b4-c51ced0210462

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-6004-620011360046224 BLISTER PACK in 1 CARTON (0113-6004-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK24 blister pack2022-08-090000-00-00NoNoCurrent