FDA.reportPublic FDA data

NDC 15331-0103 - ROMET 30

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
15331-0103
Package NDCs from labels
15331-0103-1
Manufacturer
PHARMAQ AS | International Nutrition Inc | Jiangsu Tianhe Pharmaceutical Co., Ltd.
Effective date
2023-07-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ROMET 30PHARMAQ AS | International Nutrition Inc | Jiangsu Tianhe Pharmaceutical Co., Ltd.2023-07-18VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15331-0103-1ROMET3022.68 kg in 1 CONTAINERPowder22.685

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15331-0103ROMET 30 (SULFADIMETHOXINE AND ORMETOPRIM) POWDER [PHARMAQ AS]51 package rows20230719_67a9dc76-b404-4475-b080-cb7bf62dfc86.zip

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.