NDC Code(s) : 0944-0491-01, 0944-0491-02
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:0944-0491
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 CAPRYLATE(UNII: 9XTM81VK2B)
SODIUM ACETYLTRYPTOPHANATE(UNII: 3EN9H0M2FX)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0944-0491-01250 mL in 1 BOTTLE, GLASS Type 0: Not a Combination Product
2NDC:0944-0491-02500 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 06/16/1955

PRINCIPAL DISPLAY PANEL

250mL bottle labelBuminate 5% 250 mL bottle label

Buminate 5% 250 mL bottle label

250 mL (12.5g protein)

NDC 0944-0491-01

Albumin (Human), USP, 5% Solution

BUMINATE 5%

This bottle contains 12.5 g albumin from venous plasma in saline and is osmotically equivalent to an equal volume 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 accompanying directions for use.

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

PRINCIPAL DISPLAY PANEL

500mL bottle labelBuminate 5% 500 mL bottle label

Buminate 5% 500 mL bottle label

500 mL (25 g protein)

NDC 0944-0491-02

Albumin (Human), USP, 5% Solution

BUMINATE 5%

This bottle contains 25g albumin from venous plasma in saline and is osmotically equivalent to an equal volume of normal human plasma. It has been stabilized with sodium caprylate and N-acetyltryptophan and heated for 10 hours at 60ºC. The sodium content is 145 ± 15 mEq/L. Contains no preservative. Store at room temperature, not to exceed 30ºC (86ºF). Avoid freezing to prevent damage to the bottle. See accompanying directions for use.

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