FDA.reportPublic FDA data

Pulmotech MAA

Product NDC
69945-139
11-digit product format
699450139
Labeler code
69945
Product ID
69945-139_702e29eb-f585-45b4-93ff-4d83e2788513
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
kit for the preparation of technetium Tc 99m albumin aggregated
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Route
INTRAPERITONEAL; INTRAVENOUS
Labeler
Curium US LLC
Application
BLA210089
Marketing category
BLA
Marketing start
2020-03-20
Substance
ALBUMIN AGGREGATED
Active strength
2 mg/15mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALBUMIN AGGREGATED2 mg/15mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
799C8VF17RInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a8b7adf0-2c6b-4acd-96d3-a099306951a0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f7dad750-daf9-425b-8ac2-64bb8c2d27e8Product name120200714

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69945-139-10Pulmotech MAA15 mL in 1 VIAL, MULTI-DOSEINJECTION, POWDER, LYOPHILIZED,1526
69945-139-20Pulmotech MAA5 in 1 CELLO PACKINJECTION, POWDER, LYOPHILIZED,526
69945-139-40Pulmotech MAA30 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,3026

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69945-139PULMOTECH MAA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M ALBUMIN AGGREGATED) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [CURIUM US LLC]23Current NDC, Legacy NDC, 3 package rows20230831_a8b7adf0-2c6b-4acd-96d3-a099306951a0.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
Pulmotech MAAKIT FOR THE PREPARATION OF TECHNETIUM TC 99M ALBUMIN AGGREGATEDCurium US LLCa8b7adf0-2c6b-4acd-96d3-a099306951a02025-10-13Warnings, Adverse reactionsExact identifier
application number: BLA210089
ndc (product): 69945-139

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
210089Pulmotech MAAkit for the preparation of technetium Tc-99m albumin aggregated351(a)Rx2026-07-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69945-139-106994501391015 mL in 1 VIAL, MULTI-DOSE15 mlHistorical
69945-139-20699450139205 VIAL, MULTI-DOSE in 1 CELLO PACK (69945-139-20) / 15 mL in 1 VIAL, MULTI-DOSE (69945-139-10) 2020-03-200000-00-00NoNoCurrent
69945-139-406994501394030 VIAL, MULTI-DOSE in 1 CARTON (69945-139-40) / 15 mL in 1 VIAL, MULTI-DOSE (69945-139-10) 2020-03-200000-00-00NoNoCurrent