Good Sense anti diarrheal

Product NDC
68788-8750
11-digit product format
687888750
Labeler code
68788
Product ID
68788-8750_291188e6-8d9d-4064-87b6-a13d84d39325
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA075232
Marketing category
ANDA
Marketing start
2024-10-11
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
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
68788-8750-2Good Sense anti diarrheal24 in 1 CARTONTABLET, FILM COATED242
68788-8750-2Good Sense anti diarrheal1 in 1 BLISTER PACKTABLET, FILM COATED12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8750-2EA - Each68788-87503bc468ed-29a5-4b5e-9166-0e5e61b33a8312024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8750GOOD SENSE ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 2 package rows20241013_803f492d-183d-423f-b05c-48f06dc9f2a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSN803f492d-183d-423f-b05c-48f06dc9f2a52
978010loperamide hydrochloride 2 MG Oral TabletSCD803f492d-183d-423f-b05c-48f06dc9f2a52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8750-26878887500224 BLISTER PACK in 1 CARTON (68788-8750-2) / 1 TABLET, FILM COATED in 1 BLISTER PACK24 blister pack2024-10-11NoNoHistorical