NDC 58177-002 - Disopyramide Phosphate ER

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
58177-002
Package NDCs from labels
58177-002-04
Manufacturer
ETHEX
Effective date
2007-02-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Disopyramide Phosphate ER - ETHEXETHEX2007-02-21Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58177-002-04Disopyramide Phosphate ER100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58177-002DISOPYRAMIDE PHOSPHATE ER (DISOPYRAMIDE PHOSPHATE) CAPSULE, EXTENDED RELEASE [ETHEX]11 package rows20080313_3b95acd8-1cce-4b76-9cb2-6e9ea40e54b1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Disopyramide PhosphateACTIVE INGREDIENTN6BOM1935WDISOPYRAMIDE PHOSPHATE ER (DISOPYRAMIDE PHOSPHATE) CAPSULE, EXTENDED RELEASE [ETHEX]1
DisopyramideACTIVE MOIETYGFO928U8MQDISOPYRAMIDE PHOSPHATE ER (DISOPYRAMIDE PHOSPHATE) CAPSULE, EXTENDED RELEASE [ETHEX]1
aluminum hydrateINACTIVE INGREDIENTDISOPYRAMIDE PHOSPHATE ER (DISOPYRAMIDE PHOSPHATE) CAPSULE, EXTENDED RELEASE [ETHEX]1
black iron oxideINACTIVE INGREDIENTDISOPYRAMIDE PHOSPHATE ER (DISOPYRAMIDE PHOSPHATE) CAPSULE, EXTENDED RELEASE [ETHEX]1
calcium stearateINACTIVE INGREDIENT776XM7047LDISOPYRAMIDE PHOSPHATE ER (DISOPYRAMIDE PHOSPHATE) CAPSULE, EXTENDED RELEASE [ETHEX]1
D&C Red No. 28INACTIVE INGREDIENTDISOPYRAMIDE PHOSPHATE ER (DISOPYRAMIDE PHOSPHATE) CAPSULE, EXTENDED RELEASE [ETHEX]1
D&C Yellow No. 10INACTIVE INGREDIENTDISOPYRAMIDE PHOSPHATE ER (DISOPYRAMIDE PHOSPHATE) CAPSULE, EXTENDED RELEASE [ETHEX]1
dibutyl sebacateINACTIVE INGREDIENT4W5IH7FLNYDISOPYRAMIDE PHOSPHATE ER (DISOPYRAMIDE PHOSPHATE) CAPSULE, EXTENDED RELEASE [ETHEX]1
ethylcelluloseINACTIVE INGREDIENTDISOPYRAMIDE PHOSPHATE ER (DISOPYRAMIDE PHOSPHATE) CAPSULE, EXTENDED RELEASE [ETHEX]1
FD&C Blue No. 1INACTIVE INGREDIENTDISOPYRAMIDE PHOSPHATE ER (DISOPYRAMIDE PHOSPHATE) CAPSULE, EXTENDED RELEASE [ETHEX]1
FD&C Red No. 40INACTIVE INGREDIENTDISOPYRAMIDE PHOSPHATE ER (DISOPYRAMIDE PHOSPHATE) CAPSULE, EXTENDED RELEASE [ETHEX]1
gelatinINACTIVE INGREDIENT2G86QN327LDISOPYRAMIDE PHOSPHATE ER (DISOPYRAMIDE PHOSPHATE) CAPSULE, EXTENDED RELEASE [ETHEX]1
lecithinINACTIVE INGREDIENTDISOPYRAMIDE PHOSPHATE ER (DISOPYRAMIDE PHOSPHATE) CAPSULE, EXTENDED RELEASE [ETHEX]1
pharmaceutical glazeINACTIVE INGREDIENTDISOPYRAMIDE PHOSPHATE ER (DISOPYRAMIDE PHOSPHATE) CAPSULE, EXTENDED RELEASE [ETHEX]1
povidoneINACTIVE INGREDIENTFZ989GH94EDISOPYRAMIDE PHOSPHATE ER (DISOPYRAMIDE PHOSPHATE) CAPSULE, EXTENDED RELEASE [ETHEX]1
simethiconeINACTIVE INGREDIENTDISOPYRAMIDE PHOSPHATE ER (DISOPYRAMIDE PHOSPHATE) CAPSULE, EXTENDED RELEASE [ETHEX]1
starchINACTIVE INGREDIENTDISOPYRAMIDE PHOSPHATE ER (DISOPYRAMIDE PHOSPHATE) CAPSULE, EXTENDED RELEASE [ETHEX]1
sucroseINACTIVE INGREDIENTC151H8M554DISOPYRAMIDE PHOSPHATE ER (DISOPYRAMIDE PHOSPHATE) CAPSULE, EXTENDED RELEASE [ETHEX]1
talcINACTIVE INGREDIENT7SEV7J4R1UDISOPYRAMIDE PHOSPHATE ER (DISOPYRAMIDE PHOSPHATE) CAPSULE, EXTENDED RELEASE [ETHEX]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDISOPYRAMIDE PHOSPHATE ER (DISOPYRAMIDE PHOSPHATE) CAPSULE, EXTENDED RELEASE [ETHEX]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NorpaceDISOPYRAMIDE PHOSPHATEPfizer Laboratories Div Pfizer Ince2aa1642-d262-4520-bc6a-9fd3ad7956772026-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 636794
73A6FCEC-2E13-2EA3-8278-EA9FCBB3DBBD3b95acd8-1cce-4b76-9cb2-6e9ea40e54b12007-02-21Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 73A6FCEC-2E13-2EA3-8278-EA9FCBB3DBBD
spl set id: 3b95acd8-1cce-4b76-9cb2-6e9ea40e54b1

Reported adverse events (FAERS/openFDA)#

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