NDC Code(s) : 64208-2512-8, 64208-2512-7, 64208-2512-4, 64208-2512-3
Packager : BPL

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ALBUMINEXAlbumin Human SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64208-2512
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Albumin Human(UNII: ZIF514RVZR)
(Albumin Human - UNII:ZIF514RVZR) 		Albumin Human0.25 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride(UNII: 451W47IQ8X)
Sodium Hydroxide(UNII: 55X04QC32I)
Caprylic Acid(UNII: OBL58JN025)
N-ACETYL-DL-TRYPTOPHAN SODIUM(UNII: 3EN9H0M2FX)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:64208-2512-71 in 1 CARTON 27/05/2020
1NDC:64208-2512-8100 mL in 1 VIAL, GLASS Type 0: Not a Combination Product
2NDC:64208-2512-31 in 1 CARTON 27/05/2020
2NDC:64208-2512-450 mL in 1 VIAL, GLASS Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125644 05/27/2020

LABELER - BPL(216845337)

PRINCIPAL DISPLAY PANEL

NDC 64208-2512-8

Albumin (Human) - kjda

solution for infusion
For intravenous use only

  • Do not use if turbid.
  • Do not begin administration 4 hours
    after the vial has been pierced.

Marketed by: Kedrion Biopharma, Inc,
400 Kelby St., Fort Lee, NJ 07024, United States

PRINCIPAL DISPLAY PANEL - 100 mL Vial Label

PRINCIPAL DISPLAY PANEL

NDC 64208-2512-7

Albumin (Human) - kjda

ALBUMINEX® 25%

25 g

solution for infusion

For intravenous use only

Rx only

1 vial

100 mL

Bio Products Laboratory

PRINCIPAL DISPLAY PANEL - 100 mL Vial Carton

PRINCIPAL DISPLAY PANEL

NDC 64208-2512-4

Albumin (Human) - kjda

solution for infusion
For intravenous use only

  • Do not use if turbid.
  • Do not begin administration 4 hours
    after the vial has been pierced.

Marketed by: Kedrion Biopharma, Inc,
400 Kelby St., Fort Lee, NJ 07024, United States

PRINCIPAL DISPLAY PANEL - 50 mL Vial Label

PRINCIPAL DISPLAY PANEL

NDC 64208-2512-3

Albumin (Human) - kjda

ALBUMINEX® 25%

12.5 g

solution for infusion

For intravenous use only

Rx only

1 vial

50 mL

Bio Products Laboratory

PRINCIPAL DISPLAY PANEL - 50 mL Vial Carton