FDA.reportPublic FDA data

Good Sense anti diarrheal

Product NDC
0113-0224
11-digit product format
001130224
Labeler code
0113
Product ID
0113-0224_d79c9122-ab64-4596-8496-cef5ada33d66
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA075232
Marketing category
ANDA
Marketing start
2003-02-25
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
Good Sense 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
0113-0224-53Good Sense anti diarrheal1 in 1 BLISTER PACKTABLET, FILM COATED15
0113-0224-53Good Sense anti diarrheal12 in 1 CARTONTABLET, FILM COATED125
0113-0224-62Good Sense anti diarrheal24 in 1 CARTONTABLET, FILM COATED245
0113-0224-62Good Sense anti diarrheal1 in 1 BLISTER PACKTABLET, FILM COATED15
0113-0224-89Good Sense anti diarrheal1 in 1 BLISTER PACKTABLET, FILM COATED15
0113-0224-89Good Sense anti diarrheal18 in 1 CARTONTABLET, FILM COATED185
0113-0224-91Good Sense anti diarrheal1 in 1 BLISTER PACKTABLET, FILM COATED15
0113-0224-91Good Sense anti diarrheal6 in 1 CARTONTABLET, FILM COATED65

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0224-53EA - Each0113-022482f37fcd-535a-4658-ae9d-02adb360891a12012-07-24
0113-0224-62EA - Each0113-02245fc913a4-4865-4137-9e4b-9fe452f8de5912016-09-02
0113-0224-89EA - Each0113-02246379b962-3cbe-4ac9-a7de-c1304f605d8512012-07-24
0113-0224-91EA - Each0113-02244b818f88-0e14-405e-9562-867abab5243b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CGOOD SENSE ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [L PERRIGO COMPANY]1
LOPERAMIDEACTIVE MOIETY6X9OC3H4IIGOOD SENSE ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [L PERRIGO COMPANY]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKGOOD SENSE ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [L PERRIGO COMPANY]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZGOOD SENSE ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [L PERRIGO COMPANY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGOOD SENSE ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [L PERRIGO COMPANY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGOOD SENSE ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [L PERRIGO COMPANY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GOOD SENSE ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [L PERRIGO COMPANY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGOOD SENSE ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [L PERRIGO COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0224GOOD SENSE ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [L. PERRIGO COMPANY]4Current NDC, Legacy NDC, 8 package rows20221105_9c1d811d-f8d0-418c-aaf7-7b6477deea20.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSN9c1d811d-f8d0-418c-aaf7-7b6477deea205
978010loperamide hydrochloride 2 MG Oral TabletSCD9c1d811d-f8d0-418c-aaf7-7b6477deea205
978010loperamide HCl 2 MG Oral TabletPSN345be8d9-4fc9-40a2-a9f3-775d48beb85b3
978010loperamide hydrochloride 2 MG Oral TabletSCD345be8d9-4fc9-40a2-a9f3-775d48beb85b3
978010loperamide HCl 2 MG Oral TabletPSN803f492d-183d-423f-b05c-48f06dc9f2a52
978010loperamide HCl 2 MG Oral TabletPSNdb47cc0a-e301-0310-e053-2a95a90a7f5d2
978010loperamide hydrochloride 2 MG Oral TabletSCD803f492d-183d-423f-b05c-48f06dc9f2a52
978010loperamide hydrochloride 2 MG Oral TabletSCDdb47cc0a-e301-0310-e053-2a95a90a7f5d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0224-530011302245312 BLISTER PACK in 1 CARTON (0113-0224-53) / 1 TABLET, FILM COATED in 1 BLISTER PACK12 blister pack2003-03-080000-00-00NoNoCurrent
0113-0224-620011302246224 BLISTER PACK in 1 CARTON (0113-0224-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK24 blister pack2010-03-250000-00-00NoNoCurrent
0113-0224-89001130224891 in 1 BLISTER PACKHistorical
0113-0224-91001130224916 BLISTER PACK in 1 CARTON (0113-0224-91) / 1 TABLET, FILM COATED in 1 BLISTER PACK6 blister pack2003-02-250000-00-00NoNoCurrent