NDC Code(s) : 0944-0482-01, 0944-0482-02
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:0944-0482
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 HUMAN0.2 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:0944-0482-0150 mL in 1 BOTTLE, GLASS Type 0: Not a Combination Product
2NDC:0944-0482-02100 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
Export only 03/17/1954

PRINCIPAL DISPLAY PANEL

Buminate 20% 50 mL Bottle LabelBuminate 20% 50 mL bottle label

Buminate 20% 50 mL bottle label

50 mL (10 g protein)

NDC 0944-0482-01

Albumin (Human), USP, 20% Solution

BUMINATE 20%

This bottle contains 10 g albumin from venous plasma in buffered diluent and is osmotically equivalent to 200 mL of normal human plasma. It has been stabilized with sodium caprylate and N-acetyltryptophan 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 exceed 30°C (86°F). Avoid freezing to prevent damage to the bottle. See attached 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

US. License No. 2020

Buminate 20% 50 mL Bottle LabelBuminate 20% 100 mL bottle label

Buminate 20% 100 mL bottle label

100 mL (20 g protein)

NDC 0944-0482-02

Albumin (Human), USP, 20% Solution

BUMINATE 20%

This bottle contains 20 g albumin from venous plasma in buffered diluent and is osmotically equivalent to 400 mL of normal human plasma. It has been stabilized with sodium caprylate and N-acetyltryptophan 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 exceed 30°C (86°F). Avoid freezing to prevent damage to the bottle. See attached 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

US. License No. 2020