NDC 69945-139

Pulmotech MAA

Kit For The Preparation Of Technetium Tc 99m Albumin Aggregated

Pulmotech MAA is a Intraperitoneal; Intravenous Injection, Powder, Lyophilized, For Suspension in the Human Prescription Drug category. It is labeled and distributed by Curium Us Llc. The primary component is Albumin Aggregated.

Product ID69945-139_117e6b70-55b8-48c1-b79c-edc4f00ad5eb
NDC69945-139
Product TypeHuman Prescription Drug
Proprietary NamePulmotech MAA
Generic NameKit For The Preparation Of Technetium Tc 99m Albumin Aggregated
Dosage FormInjection, Powder, Lyophilized, For Suspension
Route of AdministrationINTRAPERITONEAL; INTRAVENOUS
Marketing Start Date2020-03-20
Marketing CategoryBLA / BLA
Application NumberBLA210089
Labeler NameCurium US LLC
Substance NameALBUMIN AGGREGATED
Active Ingredient Strength2 mg/15mL
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 69945-139-20

5 VIAL, MULTI-DOSE in 1 CELLO PACK (69945-139-20) > 15 mL in 1 VIAL, MULTI-DOSE (69945-139-10)
Marketing Start Date2020-03-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69945-139-20 [69945013920]

Pulmotech MAA INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Marketing CategoryBLA
Application NumberBLA210089
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-20

NDC 69945-139-10 [69945013910]

Pulmotech MAA INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Marketing CategoryBLA
Application NumberBLA210089
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-20

NDC 69945-139-40 [69945013940]

Pulmotech MAA INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Marketing CategoryBLA
Application NumberBLA210089
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-20

Drug Details

Active Ingredients

IngredientStrength
ALBUMIN AGGREGATED2 mg/15mL

NDC Crossover Matching brand name "Pulmotech MAA" or generic name "Kit For The Preparation Of Technetium Tc 99m Albumin Aggregated"

NDCBrand NameGeneric Name
69945-139Pulmotech MAAkit for the preparation of technetium Tc 99m albumin aggregated
65174-270DRAXIMAGE MAAKit for the Preparation of Technetium Tc 99m Albumin Aggregated

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