NDC Code(s) : 76125-784-21, 76125-784-20, 76125-784-26, 76125-784-25, 76125-784-11, 76125-784-10
Packager : KEDRION BIOPHARMA, INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Albuked Albumin (Human) SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76125-784
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 Human5 g in 20 mL
Inactive Ingredients
Ingredient Name Strength
Acetyltryptophan, Dl-(UNII: 4460NBV53F)
Sodium Caprylate(UNII: 9XTM81VK2B)
Water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76125-784-201 in 1 CARTON
1NDC:76125-784-2120 mL in 1 VIAL Type 0: Not a Combination Product
2NDC:76125-784-251 in 1 CARTON
2NDC:76125-784-2650 mL in 1 VIAL Type 0: Not a Combination Product
3NDC:76125-784-101 in 1 CARTON
3NDC:76125-784-11100 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101138 10/21/1942

PRINCIPAL DISPLAY PANEL

Albumin (Human)
25%, USP

albuked™ 25

Heated 60°C 10 hours

For Intravenous Infusion Only

This package contains:
12.5 g albumin (human) in 50 mL aqueous diluent buffered with sodium carbonate and stabilized with 0.02 M sodium caprylate and 0.02 M acetyltryptophan.

Each 50 mL of product is osmotically equivalent to 250 mL of plasma.

Approximate sodium content: 145 mEq/L. Contains no preservative.

DO NOT USE IF TURBID. DO NOT BEGIN ADMINISTRATION MORE THAN 4 HOURS AFTER THE CONTAINER HAS BEEN ENTERED.
50 mL

NDC 76125-784-25

The patient and physician should discuss the risks and benefits of this product.

CAUTION: In the presence of dehydration, albumin must be given with or followed by addition of fluids.

Dosage and Administration: Read enclosed package insert.

Single Dose Vial

Store at room temperature not exceeding 30°C (86°F). Do not freeze.

If the shrink band is absent or shows any sign of tampering, do not use the product and notify Grifols Therapeutics Inc. immediately.

Not Returnable for Credit or Exchange

CAUTION: U.S. federal law prohibits dispensing without prescription.

Rx only

Manufactured by:
Grifols Therapeutics Inc.
Research Triangle Park, NC 27709 USA
U.S. License No. 1871

For:
Kedrion Biopharma, Inc.
400 Kelby Street
Fort Lee, NJ 07024

Carton: 08940735

NDC 76125-784-26

Albumin (Human)
25%, USP

albuked™ 25

50 mL

Single Dose Vial

Manufactured by: Grifols Therapeutics Inc.
Research Triangle Park, NC 27709 USA
U.S. License No. 1871

For: Kedrion Biopharma, Inc.
400 Kelby Street, Fort Lee, NJ 07024

Rx only

The patient and physician should discuss the risks and benefits of this product.

DO NOT USE IF TURBID. DO NOT BEGIN ADMINISTRATION MORE THAN 4 HOURS AFTER THE CONTAINER HAS BEEN ENTERED.

For Intravenous Infusion Only
Contains 12.5 g albumin (human) in 50 mL aqueous diluent buffered with sodium carbonate and stabilized with 0.02 M sodium caprylate and 0.02 M acetyltryptophan. Each 50 mL is osmotically equivalent to 250 mL of plasma. Approximate sodium content: 145 mEq/L.

Contains no preservative. Any unused portion must be discarded.

Caution: In the presence of dehydration, albumin must be given with or followed by addition of fluids.

Dosage and Administration: Read package insert.

Lot

Exp.

Mfd.

08940711