E-Z-Disk

Product NDC
10361-778
11-digit product format
103610778
Labeler code
10361
Product ID
10361-778_29014e07-78d9-38c1-1945-8cb44ec6f69b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
barium sulfate
Dosage form
TABLET
Route
ORAL
Labeler
E-Z-EM, INC.
Application
NDA219840
Marketing category
NDA
Marketing start
2009-02-01
Substance
BARIUM SULFATE
Active strength
700 mg/1
Pharmacologic classes
Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N219840-001E-Z-DISKBARIUM SULFATE700MGTABLET / ORALRLD, RS2025-08-01

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N219840-001E-Z-DISK700MGTABLET / ORALRLD, RS2025-08-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219840-001E-Z-DISK700MGTABLET / ORALRLD, RS2025-08-0131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219840-001E-Z-DISK700MGTABLET / ORALRLD, RS2025-08-01a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
E-Z-Disk
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BARIUM SULFATE700 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
25BB7EKE2EInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c759668b-5cf1-b237-00c8-a5e4733b6f4cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1Product name120201123
85bed648-23ca-4804-98e6-e36aee999cadProduct name120190717
80de93b4-8a94-428d-beb7-d644353ee70bProduct name120180424
eb4f7d5b-1286-40dc-b8bf-ad87ff51c688Product name120170522
db8eb201-78c7-4590-8a71-fac0a539bd8cProduct name120170404
141092be-5eb5-452e-9f69-2d350aa70a87Product name120161208

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10361-778-31E-Z-Disk100 in 1 BOTTLE, GLASSTABLET10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10361-778-31EA - Each10361-7780f1e4445-59c0-48ff-9e2f-f5cb42717fb112014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BARIUM SULFATEACTIVE INGREDIENT25BB7EKE2EE-Z-DISK (BARIUM SULFATE) TABLET [E-Z-EM, INC.]1
BARIUM SULFATEACTIVE MOIETY25BB7EKE2EE-Z-DISK (BARIUM SULFATE) TABLET [E-Z-EM, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10361-778E-Z-DISK (BARIUM SULFATE) TABLET [E-Z-EM, INC.]9Current NDC, Legacy NDC, 1 package rows20241120_c759668b-5cf1-b237-00c8-a5e4733b6f4c.zip

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
E-Z-DiskBARIUM SULFATEE-Z-EM, INC.c759668b-5cf1-b237-00c8-a5e4733b6f4c2025-09-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 219840
application number: NDA219840
ndc (product): 10361-778

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10361-778-3110361077831100 TABLET in 1 BOTTLE, GLASS (10361-778-31) 100 tablet2009-02-010000-00-00NoNoCurrent