NDC Code(s) : 64208-2510-6, 64208-2510-5, 64208-2510-2, 64208-2510-1
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:64208-2510
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 Human0.05 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:64208-2510-51 in 1 CARTON 27/05/2020
1NDC:64208-2510-6500 mL in 1 VIAL, GLASS Type 0: Not a Combination Product
2NDC:64208-2510-11 in 1 CARTON 27/05/2020
2NDC:64208-2510-2250 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 64208-2510-6

Albumin (Human) - kjda
ALBUMINEX® 5%

25 g

500 mL

solution for infusion

For intravenous use only.

  • See package insert for directions for
    use and product dosage information.
  • Do not use if turbid.
  • Do not begin administration 4 hours
    after the vial has been pierced.

Rx only
ACAUS3L

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

Manufactured by: Bio Products Laboratory Ltd.,
Elstree, Borehamwood, WD6 3BX. U.K.

U.S. License No. 1811

PRINCIPAL DISPLAY PANEL - 500 mL Vial Label

PRINCIPAL DISPLAY PANEL

NDC 64208-2510-5

Albumin (Human) - kjda
ALBUMINEX® 5%

25 g

solution for infusion

For intravenous use only

Rx only

1 vial

500 mL

Bio Products Laboratory

PRINCIPAL DISPLAY PANEL - 500 mL Vial Carton

PRINCIPAL DISPLAY PANEL

NDC 64208-2510-2

Albumin (Human) - kjda
ALBUMINEX® 5%

12.5 g

250 mL

solution for infusion

For intravenous use only.

  • See package insert for directions for
    use and product dosage information.
  • Do not use if turbid.
  • Do not begin administration 4 hours
    after the vial has been pierced.

Rx only
ACBUS3L

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

Manufactured by: Bio Products Laboratory Ltd.,
Elstree, Borehamwood, WD6 3BX. U.K.

U.S. License No. 1811

PRINCIPAL DISPLAY PANEL - 250 mL Vial Label

PRINCIPAL DISPLAY PANEL

NDC 64208-2510-1

Albumin (Human) - kjda
ALBUMINEX® 5%

12.5 g

solution for infusion

For intravenous use only

Rx only

1 vial

250 mL

Bio Products Laboratory

PRINCIPAL DISPLAY PANEL - 250 mL Vial Carton