FDA.reportPublic FDA data

berkley and jensen anti diarrheal

Product NDC
68391-224
11-digit product format
683910224
Labeler code
68391
Product ID
68391-224_16e8ebf2-bc1d-4930-9fd4-37258bfeaa6f
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
BJWC
Application
ANDA075232
Marketing category
ANDA
Marketing start
2003-04-19
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
berkley and jensen 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
68391-224-01berkley and jensen anti diarrheal2 in 1 CARTONTABLET, FILM COATED27
68391-224-01berkley and jensen anti diarrheal96 in 1 BOTTLETABLET, FILM COATED967
68391-224-62berkley and jensen anti diarrheal1 in 1 BLISTER PACKTABLET, FILM COATED17
68391-224-62berkley and jensen anti diarrheal24 in 1 CARTONTABLET, FILM COATED247

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CBERKLEY AND JENSEN ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [BJWC]2
LOPERAMIDEACTIVE MOIETY6X9OC3H4IIBERKLEY AND JENSEN ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [BJWC]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBERKLEY AND JENSEN ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [BJWC]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBERKLEY AND JENSEN ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [BJWC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBERKLEY AND JENSEN ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [BJWC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBERKLEY AND JENSEN ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [BJWC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BERKLEY AND JENSEN ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [BJWC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABERKLEY AND JENSEN ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [BJWC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-224BERKLEY AND JENSEN ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [BJWC]6Current NDC, Legacy NDC, 4 package rows20231208_dc29a8e9-f916-49d2-b9a6-d2b4537d7b58.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSNdc29a8e9-f916-49d2-b9a6-d2b4537d7b587
978010loperamide hydrochloride 2 MG Oral TabletSCDdc29a8e9-f916-49d2-b9a6-d2b4537d7b587

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68391-224-01683910224012 BOTTLE in 1 CARTON (68391-224-01) > 96 TABLET, FILM COATED in 1 BOTTLE2 bottle2003-04-190000-00-00NoNoCurrent
68391-224-626839102246224 BLISTER PACK in 1 CARTON (68391-224-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK24 blister pack2020-01-150000-00-00NoNoCurrent