FDA.reportPublic FDA data

Romifidine Hydrochloride

Manufacturer
AX Pharmaceutical Corp
Effective date
2019-06-04
Label type
BULK INGREDIENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:49:16

Label at a glance#

ProductRomifidine Hydrochloride
Active ingredientRomifidine Hydrochloride
Label structure1 sections

Label contents#

Full prescribing information#

Romifidine Hydrochloride

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62157-854-01Romifidine Hydrochloride100 g in 1 JARPOWDER1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62157-854ROMIFIDINE HYDROCHLORIDE POWDER [AX PHARMACEUTICAL CORP]11 package rows20190605_5ca39520-54b7-4e38-942e-6e15397dcd86.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62157-85462157-854-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
Romifidine Hydrochloride98LQ6RS0TAACTIM

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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