NDC 13533-613

Plasmanate

Plasma Protein Fraction (human)

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

• Product ID: 13533-613_cacac40f-5e1f-456d-849f-f8350b325285
• NDC: 13533-613
• Product Type: Plasma Derivative
• Proprietary Name: Plasmanate
• Generic Name: Plasma Protein Fraction (human)
• Dosage Form: Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1958-10-02
• Marketing Category: BLA / BLA
• Application Number: BLA101140
• Labeler Name: GRIFOLS USA, LLC
• Substance Name: ALBUMIN HUMAN
• Active Ingredient Strength: 3 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: 2019-12-31

Packaging

NDC 13533-613-20

1 VIAL in 1 CARTON (13533-613-20) > 50 mL in 1 VIAL (13533-613-21)

• Marketing Start Date: 1958-10-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 13533-613-27 [13533061327]

Plasmanate SOLUTION

• Marketing Category: BLA
• Application Number: BLA101140
• Product Type: PLASMA DERIVATIVE
• Marketing Start Date: 1958-10-02

NDC 13533-613-28 [13533061328]

Plasmanate SOLUTION

• Marketing Category: BLA
• Application Number: BLA101140
• Product Type: PLASMA DERIVATIVE
• Marketing Start Date: 2012-11-16

NDC 13533-613-25 [13533061325]

Plasmanate SOLUTION

• Marketing Category: BLA
• Application Number: BLA101140
• Product Type: PLASMA DERIVATIVE
• Billing Unit: ML
• Marketing Start Date: 1958-10-02

NDC 13533-613-20 [13533061320]

Plasmanate SOLUTION

• Marketing Category: BLA
• Application Number: BLA101140
• Product Type: PLASMA DERIVATIVE
• Billing Unit: ML
• Marketing Start Date: 1958-10-02

NDC 13533-613-26 [13533061326]

Plasmanate SOLUTION

• Marketing Category: BLA
• Application Number: BLA101140
• Product Type: PLASMA DERIVATIVE
• Billing Unit: ML
• Marketing Start Date: 2012-11-16

NDC 13533-613-21 [13533061321]

Plasmanate SOLUTION

• Marketing Category: BLA
• Application Number: BLA101140
• Product Type: PLASMA DERIVATIVE
• Billing Unit: ML
• Marketing Start Date: 2012-11-16

Drug Details

Active Ingredients

Ingredient	Strength
ALBUMIN HUMAN	2.5 g/50mL

Pharmacological Class

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