sunmark anti diarrheal

Product NDC
50090-4450
11-digit product format
500904450
Labeler code
50090
Product ID
50090-4450_3ecc5693-32d2-4d4d-99d4-ce040b36812e
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091292
Marketing category
ANDA
Marketing start
2018-06-11
Marketing end
0000-00-00
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
1 mg/7.5mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
10f838ef-a72b-645d-80f8-e2255205c3b1Product name620240805

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4450-02023-01-30C16284748780-1f386c64a-1030-0266-e053-dadaa90a7c1aMcKesson Anti-Diarrheal Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4450-0sunmark anti diarrheal120 mL in 1 BOTTLESOLUTION1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4450SUNMARK ANTI DIARRHEAL (LOPERAMIDE HCL) SOLUTION [A-S MEDICATION SOLUTIONS]3Legacy NDC, 1 package rows20210417_6302dfd9-24e0-4ec5-ade0-949666a2ab9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1250685loperamide HCl 1 MG in 7.5 mL Oral SuspensionPSN6302dfd9-24e0-4ec5-ade0-949666a2ab9e3
1250685loperamide hydrochloride 0.133 MG/ML Oral SuspensionSCD6302dfd9-24e0-4ec5-ade0-949666a2ab9e3
1250685loperamide HCl 1 MG per 7.5 ML Oral SolutionSY6302dfd9-24e0-4ec5-ade0-949666a2ab9e3
1250685loperamide hydrochloride 1 MG per 7.5 ML Oral SuspensionSY6302dfd9-24e0-4ec5-ade0-949666a2ab9e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4450-050090445000120 mL in 1 BOTTLE (50090-4450-0) 120 ml2019-08-050000-00-00NoNoCurrent