FDA.reportPublic FDA data

NDC 72189-486 - Promethazine/Codeine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
72189-486
Package NDCs from labels
72189-486-16
Manufacturer
Direct_Rx
Effective date
2023-06-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Promethazine/Codeine - Direct_RxDirect_Rx2023-06-02HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72189-486-162025-01-30C16284748780-12cef2736-9343-d83d-e063-dadaa90ab31fPromethazine/Codeine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-486-16Promethazine/Codeine473 mL in 1 BOTTLESOLUTION4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-486PROMETHAZINE/CODEINE SOLUTION [DIRECT_RX]11 package rows20230607_fd268952-e5c0-75ba-e053-6294a90a7410.zip