NDC 64208-2512

ALBUMINEX

Albumin Human

ALBUMINEX is a Intravenous Solution in the Human Prescription Drug category. It is labeled and distributed by Bpl. The primary component is Albumin Human.

• Product ID: 64208-2512_2f973a8f-cf17-4f9b-9134-d781507c6436
• NDC: 64208-2512
• Product Type: Human Prescription Drug
• Proprietary Name: ALBUMINEX
• Generic Name: Albumin Human
• Dosage Form: Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2016-07-12
• Marketing Category: BLA / BLA
• Application Number: BLA125644
• Labeler Name: BPL
• Substance Name: ALBUMIN HUMAN
• Active Ingredient Strength: 0 g/mL
• 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: 2020-12-31

Packaging

NDC 64208-2512-3

1 VIAL, GLASS in 1 CARTON (64208-2512-3) > 50 mL in 1 VIAL, GLASS (64208-2512-4)

• Marketing Start Date: 2020-05-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 64208-2512-3 [64208251203]

ALBUMINEX SOLUTION

• Marketing Category: BLA
• Application Number: BLA125644
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2020-02-01

NDC 64208-2512-4 [64208251204]

ALBUMINEX SOLUTION

• Marketing Category: BLA
• Application Number: BLA125644
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-05-10

NDC 64208-2512-7 [64208251207]

ALBUMINEX SOLUTION

• Marketing Category: BLA
• Application Number: BLA125644
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2020-02-01

NDC 64208-2512-8 [64208251208]

ALBUMINEX SOLUTION

• Marketing Category: BLA
• Application Number: BLA125644
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-05-10

Drug Details

Active Ingredients

Ingredient	Strength
ALBUMIN HUMAN	.25 g/mL

OpenFDA Data

• SPL SET ID: 167f48d0-8ae5-4f7e-b050-9673dad78acc
• Manufacturer:
  • BPL
• UNII:
  • ZIF514RVZR
• RxNorm Concept Unique ID - RxCUI:
  • 2054174
  • 2054173
  • 2054170
  • 2054168

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 "ALBUMINEX" or generic name "Albumin Human"

NDC	Brand Name	Generic Name
64208-2510	ALBUMINEX	Albumin Human
64208-2512	ALBUMINEX	Albumin Human
67467-623	Albumin (Human)	Albumin Human
67467-633	Albumin (Human)	Albumin Human
67467-643	Albumin (Human)	Albumin Human
68982-623	Albumin (Human)	Albumin Human
68982-633	Albumin (Human)	Albumin Human
68982-643	Albumin (Human)	Albumin Human
0944-0493	FLEXBUMIN	Albumin Human
0944-0495	Flexbumin	Albumin Human