Good Sense anti diarrheal

Product NDC
51655-663
11-digit product format
516550663
Labeler code
51655
Product ID
51655-663_4950ae3a-d3c7-b948-e063-6394a90afa44
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA075232
Marketing category
ANDA
Marketing start
2021-04-02
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
51655-663-54Good Sense anti diarrheal15 in 1 BAGTABLET, FILM COATED152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-663GOOD SENSE ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]1Current NDC, 1 package rows20230321_db47cc0a-e301-0310-e053-2a95a90a7f5d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSNdb47cc0a-e301-0310-e053-2a95a90a7f5d2
978010loperamide hydrochloride 2 MG Oral TabletSCDdb47cc0a-e301-0310-e053-2a95a90a7f5d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-663-545165506635415 TABLET, FILM COATED in 1 BAG (51655-663-54) 2021-04-02NoNoCurrent