FDA.reportPublic FDA data

topcare anti diarrheal

Product NDC
36800-224
11-digit product format
368000224
Labeler code
36800
Product ID
36800-224_1d9293db-7ead-4316-a8a3-2c5ff664772c
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA075232
Marketing category
ANDA
Marketing start
2003-02-26
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
topcare anti diarrheal
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
36800-224-53topcare anti diarrheal12 in 1 CARTONTABLET, FILM COATED127
36800-224-53topcare anti diarrheal1 in 1 BLISTER PACKTABLET, FILM COATED17
36800-224-62topcare anti diarrheal24 in 1 CARTONTABLET, FILM COATED247
36800-224-62topcare anti diarrheal1 in 1 BLISTER PACKTABLET, FILM COATED17
36800-224-80topcare anti diarrheal1 in 1 CARTONTABLET, FILM COATED17
36800-224-80topcare anti diarrheal96 in 1 BOTTLETABLET, FILM COATED967
36800-224-91topcare anti diarrheal6 in 1 CARTONTABLET, FILM COATED67
36800-224-91topcare anti diarrheal1 in 1 BLISTER PACKTABLET, FILM COATED17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-224TOPCARE ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]6Current NDC, Legacy NDC, 8 package rows20211201_da347b47-d8a5-4cf9-9579-79e6fe57fed5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSNda347b47-d8a5-4cf9-9579-79e6fe57fed57
978010loperamide hydrochloride 2 MG Oral TabletSCDda347b47-d8a5-4cf9-9579-79e6fe57fed57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-224-533680002245312 BLISTER PACK in 1 CARTON (36800-224-53) / 1 TABLET, FILM COATED in 1 BLISTER PACK12 blister pack2003-02-260000-00-00NoNoCurrent
36800-224-623680002246224 BLISTER PACK in 1 CARTON (36800-224-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK24 blister pack2003-04-220000-00-00NoNoCurrent
36800-224-80368000224801 BOTTLE in 1 CARTON (36800-224-80) > 96 TABLET, FILM COATED in 1 BOTTLE1 bottle2007-11-120000-00-00NoNoCurrent
36800-224-91368000224916 BLISTER PACK in 1 CARTON (36800-224-91) / 1 TABLET, FILM COATED in 1 BLISTER PACK6 blister pack2003-08-070000-00-00NoNoCurrent