NDC 68516-5215

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 ID: 68516-5215_1bf03b1c-9ee1-4685-aa1c-c2f24ed21488
• NDC: 68516-5215
• Product Type: Plasma Derivative
• Proprietary Name: ALBUTEIN
• Generic Name: Albumin (human)
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1978-08-15
• Marketing Category: BLA / BLA
• Application Number: BLA102478
• Labeler Name: GRIFOLS USA, LLC
• Substance Name: ALBUMIN HUMAN
• Active Ingredient Strength: 10 g/50mL
• Pharm Classes: Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 68516-5215-1

1 VIAL in 1 CARTON (68516-5215-1) > 50 mL in 1 VIAL (68516-5215-3)

• Marketing Start Date: 1978-08-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68516-5215-3 [68516521503]

ALBUTEIN INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102478
• Product Type: PLASMA DERIVATIVE
• Marketing Start Date: 2013-02-13

NDC 68516-5215-2 [68516521502]

ALBUTEIN INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102478
• Product Type: PLASMA DERIVATIVE
• Marketing Start Date: 1978-08-15

NDC 68516-5215-4 [68516521504]

ALBUTEIN INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102478
• Product Type: PLASMA DERIVATIVE
• Marketing Start Date: 2013-02-13

NDC 68516-5215-1 [68516521501]

ALBUTEIN INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102478
• Product Type: PLASMA DERIVATIVE
• Marketing Start Date: 1978-08-15

Drug Details

Active Ingredients

Ingredient	Strength
ALBUMIN HUMAN	10 g/50mL

Pharmacological Class

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

NDC	Brand Name	Generic Name
68516-5214	ALBUTEIN	ALBUMIN (HUMAN)
68516-5215	ALBUTEIN	ALBUMIN (HUMAN)
68516-5216	ALBUTEIN	ALBUMIN (HUMAN)
0053-7680	Albuminar-25	Albumin (Human)
0053-7670	Albuminar-5	Albumin (Human)
44206-251	AlbuRx	ALBUMIN (HUMAN)
44206-310	ALBURX	ALBUMIN (HUMAN)
61953-0001	HUMAN ALBUMIN GRIFOLS	ALBUMIN (HUMAN)
61953-0002	HUMAN ALBUMIN GRIFOLS	ALBUMIN (HUMAN)
13533-683	Plasbumin	Albumin (Human)
13533-684	Plasbumin	Albumin (Human)
13533-690	Plasbumin	Albumin (Human)
13533-691	Plasbumin	Albumin (Human)
13533-692	Plasbumin	Albumin (Human)