FDA.reportPublic FDA data

Megatope

Product NDC
50914-7731
11-digit product format
509147731
Labeler code
50914
Product ID
50914-7731_a0a63fb3-6957-4446-8bf0-67c91325f753
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Iodinated I-131 Albumin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Iso-Tex Diagnostics, Inc.
Application
BLA017837
Marketing category
BLA
Marketing start
1996-05-21
Substance
HUMAN SERUM ALBUMIN I-131
Active strength
1 mCi/mL
Pharmacologic classes
Radiopharmaceutical Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Megatope
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HUMAN SERUM ALBUMIN I-1311 mCi/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ACH35131L1Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
62ca4278-8cc9-46b7-8f3c-303ce6a9c155Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50914-7731-4Megatope8 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION84

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50914-7731-4EA - Each50914-7731af8261f2-d29f-40fd-a529-1f0e18859d1a12022-11-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IODINATED I-131 SERUM ALBUMINACTIVE INGREDIENTACH35131L1MEGATOPE (IODINATED I-131 ALBUMIN ) INJECTION, SOLUTION [ISO-TEX DIAGNOSTICS, INC.]1
IODINATED I-131 SERUM ALBUMINACTIVE MOIETYACH35131L1MEGATOPE (IODINATED I-131 ALBUMIN ) INJECTION, SOLUTION [ISO-TEX DIAGNOSTICS, INC.]1
ALBUMIN HUMANINACTIVE INGREDIENTZIF514RVZRMEGATOPE (IODINATED I-131 ALBUMIN ) INJECTION, SOLUTION [ISO-TEX DIAGNOSTICS, INC.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHMEGATOPE (IODINATED I-131 ALBUMIN ) INJECTION, SOLUTION [ISO-TEX DIAGNOSTICS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50914-7731MEGATOPE (IODINATED I-131 ALBUMIN ) INJECTION, SOLUTION [ISO-TEX DIAGNOSTICS, INC.]4Current NDC, Legacy NDC, 1 package rows20230908_62ca4278-8cc9-46b7-8f3c-303ce6a9c155.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MegatopeIODINATED I-131 ALBUMINIso-Tex Diagnostics, Inc.62ca4278-8cc9-46b7-8f3c-303ce6a9c1552023-09-01Warnings, Adverse reactionsExact identifier
application number: BLA017837
ndc (product): 50914-7731
VolumexIODINATED I-131 ALBUMINIso-Tex Diagnostics, Inc.812240e4-fc28-46c2-92f3-1ba4e029645a2022-11-21Warnings, Adverse reactionsExact identifier
application number: BLA017837

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
017837Megatopeiodinated I-131 albumin351(a)Disc2026-08-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50914-7731-4509147731048 mL in 1 VIAL, MULTI-DOSE (50914-7731-4) 8 ml1996-05-210000-00-00NoNoCurrent