good neighbor pharmacy loperamide hydrochloride

Product NDC
17856-0545
11-digit product format
178560545
Labeler code
17856
Product ID
17856-0545_e550f322-8b22-40e9-9fdd-77ded2f741df
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA091292
Marketing category
ANDA
Marketing start
2018-08-13
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0545-1good neighbor pharmacy loperamide hydrochloride15 mL in 1 CUP, UNIT-DOSESOLUTION152
17856-0545-1good neighbor pharmacy loperamide hydrochloride50 in 1 BOX, UNIT-DOSESOLUTION502
17856-0545-2good neighbor pharmacy loperamide hydrochloride7.5 mL in 1 CUP, UNIT-DOSESOLUTION7.52
17856-0545-2good neighbor pharmacy loperamide hydrochloride72 in 1 BOX, UNIT-DOSESOLUTION722

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0545GOOD NEIGHBOR PHARMACY LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SOLUTION [ATLANTIC BIOLOGICALS CORP.]2Legacy NDC, 4 package rows20210124_c923b712-e269-4270-bba7-972010febe83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1250685loperamide HCl 1 MG in 7.5 mL Oral SuspensionPSNc923b712-e269-4270-bba7-972010febe832
1250685loperamide hydrochloride 0.133 MG/ML Oral SuspensionSCDc923b712-e269-4270-bba7-972010febe832
1250685loperamide HCl 1 MG per 7.5 ML Oral SolutionSYc923b712-e269-4270-bba7-972010febe832
1250685loperamide hydrochloride 1 MG per 7.5 ML Oral SuspensionSYc923b712-e269-4270-bba7-972010febe832

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17856-0545-11785605450150 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0545-1) > 15 mL in 1 CUP, UNIT-DOSE2021-01-220000-00-00NoNoCurrent
17856-0545-21785605450272 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0545-2) > 7.5 mL in 1 CUP, UNIT-DOSE2021-01-220000-00-00NoNoCurrent