FDA.reportPublic FDA data

anti diarrheal

Product NDC
0363-1010
11-digit product format
003631010
Labeler code
0363
Product ID
0363-1010_8b29d4fe-54cf-45df-8849-9b57026ba151
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Walgreen Company
Application
ANDA075232
Marketing category
ANDA
Marketing start
2021-09-11
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
0363-1010-53anti diarrheal12 in 1 CARTONTABLET, FILM COATED124
0363-1010-53anti diarrheal1 in 1 BLISTER PACKTABLET, FILM COATED14
0363-1010-62anti diarrheal24 in 1 CARTONTABLET, FILM COATED244
0363-1010-62anti diarrheal1 in 1 BLISTER PACKTABLET, FILM COATED14
0363-1010-91anti diarrheal6 in 1 CARTONTABLET, FILM COATED64
0363-1010-91anti diarrheal1 in 1 BLISTER PACKTABLET, FILM COATED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1010ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [WALGREEN COMPANY]3Current NDC, Legacy NDC, 6 package rows20220615_6e0dfbb3-6c58-40fc-83b4-09ee10576ae5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSN6e0dfbb3-6c58-40fc-83b4-09ee10576ae54
978010loperamide hydrochloride 2 MG Oral TabletSCD6e0dfbb3-6c58-40fc-83b4-09ee10576ae54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-1010-530036310105312 BLISTER PACK in 1 CARTON (0363-1010-53) / 1 TABLET, FILM COATED in 1 BLISTER PACK12 blister pack2021-09-110000-00-00NoNoCurrent
0363-1010-620036310106224 BLISTER PACK in 1 CARTON (0363-1010-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK24 blister pack2021-09-140000-00-00NoNoCurrent
0363-1010-91003631010916 BLISTER PACK in 1 CARTON (0363-1010-91) / 1 TABLET, FILM COATED in 1 BLISTER PACK6 blister pack2021-09-140000-00-00NoNoCurrent