NDC 68516-5214

ALBUTEIN

Albumin (human)

ALBUTEIN is a Intravenous Injection, Solution in the Plasma Derivative category. It is labeled and distributed by Grifols Usa, Llc. The primary component is Albumin Human.

Product ID68516-5214_0784e631-4dc4-4201-966f-c501fc37d334
NDC68516-5214
Product TypePlasma Derivative
Proprietary NameALBUTEIN
Generic NameAlbumin (human)
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date1978-08-15
Marketing CategoryBLA / BLA
Application NumberBLA102478
Labeler NameGRIFOLS USA, LLC
Substance NameALBUMIN HUMAN
Active Ingredient Strength13 g/250mL
Pharm ClassesHuman Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68516-5214-1

1 VIAL in 1 CARTON (68516-5214-1) > 250 mL in 1 VIAL (68516-5214-3)
Marketing Start Date1978-08-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68516-5214-3 [68516521403]

ALBUTEIN INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102478
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2013-02-13

NDC 68516-5214-1 [68516521401]

ALBUTEIN INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102478
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date1978-08-15

NDC 68516-5214-5 [68516521405]

ALBUTEIN INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102478
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2016-07-08

NDC 68516-5214-2 [68516521402]

ALBUTEIN INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102478
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date1978-08-15

NDC 68516-5214-6 [68516521406]

ALBUTEIN INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102478
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2016-07-08

NDC 68516-5214-4 [68516521404]

ALBUTEIN INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102478
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2013-02-13

Drug Details

Active Ingredients

IngredientStrength
ALBUMIN HUMAN12.5 g/250mL

Pharmacological Class

  • Human Serum Albumin [EPC]
  • Increased Intravascular Volume [PE]
  • Increased Oncotic Pressure [PE]
  • Osmotic Activity [MoA]
  • Serum Albumin [Chemical/Ingredient]

NDC Crossover Matching brand name "ALBUTEIN" or generic name "Albumin (human)"

NDCBrand NameGeneric Name
68516-5214ALBUTEINALBUMIN (HUMAN)
68516-5215ALBUTEINALBUMIN (HUMAN)
68516-5216ALBUTEINALBUMIN (HUMAN)
76125-790AlbukedAlbumin (Human)
76125-791AlbukedAlbumin (Human)
76125-792AlbukedAlbumin (Human)
0053-7680Albuminar-25Albumin (Human)
0053-7670Albuminar-5Albumin (Human)
44206-251AlbuRxALBUMIN (HUMAN)
44206-310ALBURXALBUMIN (HUMAN)
61953-0001HUMAN ALBUMIN GRIFOLSALBUMIN (HUMAN)
61953-0002HUMAN ALBUMIN GRIFOLSALBUMIN (HUMAN)
76179-025KEDBUMINAlbumin (Human)
13533-683PlasbuminAlbumin (Human)
13533-684PlasbuminAlbumin (Human)
13533-690PlasbuminAlbumin (Human)
13533-691PlasbuminAlbumin (Human)
13533-692PlasbuminAlbumin (Human)

Trademark Results [ALBUTEIN]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ALBUTEIN
ALBUTEIN
72417224 0964012 Live/Registered
ABBOTT LABORATORIES
1972-03-03

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