NDC Code(s) : 0944-0490-01, 0944-0490-02, 0944-0490-03
Packager : Baxalta US Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BuminateAlbumin Human INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0944-0490
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 CAPRYLATE(UNII: 9XTM81VK2B)
SODIUM ACETYLTRYPTOPHANATE(UNII: 3EN9H0M2FX)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0944-0490-0120 mL in 1 BOTTLE, GLASS Type 0: Not a Combination Product
2NDC:0944-0490-0250 mL in 1 BOTTLE, GLASS Type 0: Not a Combination Product
3NDC:0944-0490-03100 mL in 1 BOTTLE, GLASS Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101452 03/17/1954

PRINCIPAL DISPLAY PANEL

50 mL Unit CartonBuminate 25% 20 mL Unit Carton

Buminate 25% 20 mL Unit Carton

20 mL (5 g protein)

NDC 0944-0490-01

Albumin (Human), USP, 25% Solution

BUMINATE 25%

For Intravenous Administration Only.

See enclosed directions for use.

Do not use if turbid. Do not begin

administration more than 4 hours

after the container has been entered.

Certain components used in the packaging of this product contain

natural rubber latex.

Caution: In patients with marked dehydration, additional fluids must

accompany or follow administration of this product.

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

Rx Only

Baxalta US Inc.

Westlake Village, CA 91362 USA

U.S. License No. 2020

50 mL Unit Carton

Buminate 25% 20 mL Booklet Label

20 mL (5 g protein)
NDC 0944-0490-01
Albumin (Human), USP, 25% Solution
Buminate 25%
Baxalta
Osmotically equivalent to 100 mL of normal human plasma.
Sodium Content is 145 ± 15 mEq/L. Contains no preservative.
See accompanying directions for use. Caution: In patients
with marked dehydration, additional fluids must accompany
or follow administration of this product. Do not use if turbid.
Do not begin administration more than 4 hours after
The container has been entered. Single dose container.
Discard partially used bottle. The patient and physician
should discuss the riska and benefits of this product.

Rx Only

Baxalta US Inc.
Westlake Village, CA 91362 USA
U.S. License No. 2020

50 mL Unit Carton

Buminate 25% 50 mL Booklet Label

50 mL (12.5 g protein)
NDC 0944-0490-02
Albumin (Human), USP, 25% Solution
Buminate 25%
Baxalta
This bottle contains 12.5 g albumin from venous plasma in buffered diluent and is osmotically
equivalent to 205 mL of normal human plasma. It has been stabilized with sodium caprylate and N-acetyltrptophan and heated for 10 hours at 60°C. The sodium content is 145 ± 15 mEq/L. Contains no preservative. Store at room temperature, not to exceet 30°C (86°F). Avoid freezing to prevent damage to the bottle. See accompanying directions for use. Caution: In patients with marked dehydration additional fluids must accompany or follow administration of this product. Do not use if turbid. Do not begin administration more than 4 hours after the container has been entered. Single dose container. Discard partially used bottle. The patient and physician should discuss the risks and benefits of this product.

Rx Only

Baxalta US Inc.
Westlake Village, CA 91362 USA
U.S. License No. 2020

50 mL Unit Carton

Buminate 25% 100 mL Booklet Label

100 mL (25 g protein)
NDC 0944-0490-03
Albumin (Human), USP, 25% Solution
Buminate 25%
Baxalta
This bottle contains 25 g albumin from venous plasma in buffered diluent and is osmotically
equivalent to 500 mL of normal human plasma. It has been stabilized with sodium caprylate and N-acetyltrptophan and heated for 10 hours at 60°C. The sodium content is 145 ± 15 mEq/L. Contains no preservative. Store at room temperature, not to exceet 30°C (86°F). Avoid freezing to prevent damage to the bottle. See accompanying directions for use.
Caution: In patients with marked dehydration additional fluids must accompany or follow administration of this product. Do not use if turbid. Do not begin administration more than 4 hours after the container has been entered. Single dose container. Discard partially used bottle. The patient and physician should discuss the risks and benefits of this product.

Rx Only

Baxalta US Inc.
Westlake Village, CA 91362 USA
U.S. License No. 2020