Loperamide Hydrochloride

Product NDC
17856-0618
11-digit product format
178560618
Labeler code
17856
Product ID
17856-0618_5a00eb66-d425-467c-a2d8-6e82a701348b
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Atlantic Biologicals Corps
Application
ANDA074352
Marketing category
ANDA
Marketing start
1995-11-17
Marketing end
0000-00-00
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
1 mg/5mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
10f838ef-a72b-645d-80f8-e2255205c3b1Product name620240805
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0618-12021-01-29C16284748780-1ba0f9c33-47fd-a910-e053-dadaa90a0b85Drug Facts
17856-0618-52021-01-29C16284748780-1ba0f9c33-47fd-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0618-1Loperamide Hydrochloride10 mL in 1 CUPSOLUTION105
17856-0618-5Loperamide Hydrochloride5 mL in 1 CUPSOLUTION55

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0618LOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]5Legacy NDC, 2 package rows20191017_b0596b9c-326d-4795-b0a5-38c858af7a77.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
977986loperamide HCl 1 MG in 5 mL Oral SolutionPSNb0596b9c-326d-4795-b0a5-38c858af7a775
977986loperamide hydrochloride 0.2 MG/ML Oral SolutionSCDb0596b9c-326d-4795-b0a5-38c858af7a775
977986loperamide hydrochloride 1 MG per 5 ML Oral SolutionSYb0596b9c-326d-4795-b0a5-38c858af7a775
977986loperamide hydrochloride 2 MG per 10 ML Oral SolutionSYb0596b9c-326d-4795-b0a5-38c858af7a775

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
17856-0618-11785606180110 mL in 1 CUP10 mlHistorical
17856-0618-5178560618055 mL in 1 CUP5 mlHistorical