NDC Code(s) : 13533-685-21, 13533-685-20, 13533-685-26, 13533-685-25, 13533-685-28, 13533-685-27
Packager : GRIFOLS USA, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Plasbumin Albumin (Human) SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13533-685
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 Human2.5 g in 50 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:13533-685-201 in 1 CARTON
1NDC:13533-685-2150 mL in 1 VIAL Type 0: Not a Combination Product
2NDC:13533-685-251 in 1 CARTON
2NDC:13533-685-26250 mL in 1 VIAL Type 0: Not a Combination Product
3NDC:13533-685-271 in 1 CARTON
3NDC:13533-685-28500 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 08/26/1976

PRINCIPAL DISPLAY PANEL

Albumin (Human)
5%, USP

Plasbumin®-5

Heated 60°C 10 hours

For Intravenous Infusion Only

This package contains: 2.5 g albumin (human) in 50 mL aqueous diluent buffered with sodium carbonate and stabilized with 0.004 M sodium caprylate and 0.004 M acetyltryptophan. Each 50 mL is osmotically equivalent to 50 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

GRIFOLS

NDC13533-685-20

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

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

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

Carton: 08940724

NDC 13533-685-21

Albumin (Human)
5%, USP

Plasbumin®-5

50 mL

Single Dose Vial

Rx only

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

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 2.5 g albumin (human) in 50 mL aqueous diluent buffered with sodium carbonate and stabilized with 0.004 M sodium caprylate and 0.004 M acetyltryptophan. Each 50 mL is osmotically equivalent to 50 mL of plasma. Approximate sodium content: 145 mEq/L.

Contains no preservative. Any unused portion must be discarded. Dosage and Administration: Read package insert.
Lot

Exp.

Mfd.

08940700