Home NDC 65174-270 DRAXIMAGE MAA
Product NDC 65174-270
11-digit product format 651740270
Labeler code 65174
Product ID 65174-270_889b7899-9b87-47c2-bb8b-dc896b305186
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Kit for the preparation of Technetium Tc 99m Albumin aggregated
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Jubilant DraxImage Inc
Application BLA017881
Marketing category BLA
Marketing start 1987-12-30
Substance ALBUMIN AGGREGATED
Active strength 2.5 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base DRAXIMAGE MAA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALBUMIN AGGREGATED 2.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 799C8VF17R Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65174-270-30 DRAXIMAGE MAA 30 in 1 KIT INJECTION, POWDER, FOR SOLUTION 30 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Albumin Aggregated ACTIVE INGREDIENT 799C8VF17R DRAXIMAGE MAA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M ALBUMIN AGGREGATED) INJECTION, POWDER, FOR SOLUTION [JUBILANT DRAXIMAGE INC.] 1 Albumin Aggregated ACTIVE MOIETY 799C8VF17R DRAXIMAGE MAA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M ALBUMIN AGGREGATED) INJECTION, POWDER, FOR SOLUTION [JUBILANT DRAXIMAGE INC.] 1 Albumin (human) INACTIVE INGREDIENT ZIF514RVZR DRAXIMAGE MAA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M ALBUMIN AGGREGATED) INJECTION, POWDER, FOR SOLUTION [JUBILANT DRAXIMAGE INC.] 1 Sodium Chloride INACTIVE INGREDIENT 451W47IQ8X DRAXIMAGE MAA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M ALBUMIN AGGREGATED) INJECTION, POWDER, FOR SOLUTION [JUBILANT DRAXIMAGE INC.] 1 Stannous Chloride INACTIVE INGREDIENT 1BQV3749L5 DRAXIMAGE MAA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M ALBUMIN AGGREGATED) INJECTION, POWDER, FOR SOLUTION [JUBILANT DRAXIMAGE INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65174-270 DRAXIMAGE MAA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M ALBUMIN AGGREGATED) INJECTION, POWDER, FOR SOLUTION [JUBILANT DRAXIMAGE INC] 11 Current NDC, Legacy NDC, 1 package rows 20240214_bbefaa05-1dc0-3ae7-7264-ce1eddf0da2b.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DRAXIMAGE MAA KIT FOR THE PREPARATION OF TECHNETIUM TC 99M ALBUMIN AGGREGATED Jubilant DraxImage Inc bbefaa05-1dc0-3ae7-7264-ce1eddf0da2b 2024-02-13 Warnings, Adverse reactions Exact identifier application number: BLA017881 ndc (product): 65174-270
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 017881 Draximage MAA kit for the preparation of technetium Tc-99m albumin aggregated 351(a) Rx 2026-07-01
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 65174-270-30 65174027030 30 INJECTION, POWDER, FOR SOLUTION in 1 KIT (65174-270-30) 1987-12-30 0000-00-00 No No Current