ALBUMINEX

Product NDC: 64208-2510
11-digit product format: 642082510
Labeler code: 64208
Product ID: 64208-2510_7a994321-a724-4f00-a7e7-95dca159394f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Albumin Human
Dosage form: SOLUTION
Route: INTRAVENOUS
Labeler: BPL
Application: BLA125644
Marketing category: BLA
Marketing start: 2020-05-27
Substance: ALBUMIN HUMAN
Active strength: .05 g/mL
Pharmacologic classes: Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
ALBUMIN HUMAN	.05 g/mL

Field, Values table
Field	Values
Unii	ZIF514RVZR
Rxcui	2054221, 2054223, 2054226, 2054227

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
64208-2510-1	ALBUMINEX	1 in 1 CARTON	SOLUTION	1	8
64208-2510-2	ALBUMINEX	250 mL in 1 VIAL, GLASS	SOLUTION	250	8
64208-2510-5	ALBUMINEX	1 in 1 CARTON	SOLUTION	1	8
64208-2510-6	ALBUMINEX	500 mL in 1 VIAL, GLASS	SOLUTION	500	8

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64208-2510-1	ML - Milliliter	64208-2510	c817340a-bc73-4a0f-a637-e6d3d057a070	1	2018-12-13
64208-2510-2	ML - Milliliter	64208-2510	69981ae2-6a04-48ac-82d5-5b763d8ddfc9	1	2019-06-19
64208-2510-5	ML - Milliliter	64208-2510	94cedc37-4d03-4eee-aed5-290ec19f52c6	1	2018-12-13
64208-2510-6	ML - Milliliter	64208-2510	134336fb-9c27-46bd-a4aa-286375dc3205	1	2019-06-19

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64208-2510	ALBUMINEX (ALBUMIN HUMAN) SOLUTION [BPL]	8	Current NDC, Legacy NDC, 4 package rows	20250109_8428d373-f4b1-4e3b-bb19-ea89048f7c79.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ZIF514RVZR	ALBUMIN HUMAN	9048-46-8	ALBUMIN HUMAN

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2054221	albumin human-kjda 5 % in 250 ML Injection	PSN	8428d373-f4b1-4e3b-bb19-ea89048f7c79	8
2054226	albumin human-kjda 5 % in 500 ML Injection	PSN	8428d373-f4b1-4e3b-bb19-ea89048f7c79	8
2054223	ALBUMINEX 5 % in 250 ML Injection	PSN	8428d373-f4b1-4e3b-bb19-ea89048f7c79	8
2054227	ALBUMINEX 5 % in 500 ML Injection	PSN	8428d373-f4b1-4e3b-bb19-ea89048f7c79	8
2054223	250 ML albumin human-kjda 50 MG/ML Injection [Albuminex]	SBD	8428d373-f4b1-4e3b-bb19-ea89048f7c79	8
2054227	500 ML albumin human-kjda 50 MG/ML Injection [Albuminex]	SBD	8428d373-f4b1-4e3b-bb19-ea89048f7c79	8
2054221	250 ML albumin human-kjda 50 MG/ML Injection	SCD	8428d373-f4b1-4e3b-bb19-ea89048f7c79	8
2054226	500 ML albumin human-kjda 50 MG/ML Injection	SCD	8428d373-f4b1-4e3b-bb19-ea89048f7c79	8
2054221	albumin human-kjda 5 % per 250 ML Injection	SY	8428d373-f4b1-4e3b-bb19-ea89048f7c79	8
2054226	albumin human-kjda 5 % per 500 ML Injection	SY	8428d373-f4b1-4e3b-bb19-ea89048f7c79	8
2054221	albumin human-kjda 50 MG/ML per 250 ML Injection	SY	8428d373-f4b1-4e3b-bb19-ea89048f7c79	8
2054226	albumin human-kjda 50 MG/ML per 500 ML Injection	SY	8428d373-f4b1-4e3b-bb19-ea89048f7c79	8
2054223	Albuminex 5 % per 250 ML Injection	SY	8428d373-f4b1-4e3b-bb19-ea89048f7c79	8
2054227	Albuminex 5 % per 500 ML Injection	SY	8428d373-f4b1-4e3b-bb19-ea89048f7c79	8
2054223	Albuminex 50 MG/ML per 250 ML Injection	SY	8428d373-f4b1-4e3b-bb19-ea89048f7c79	8
2054227	Albuminex 50 MG/ML per 500 ML Injection	SY	8428d373-f4b1-4e3b-bb19-ea89048f7c79	8

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64208-2510-1	64208251001	1 VIAL, GLASS in 1 CARTON (64208-2510-1) / 250 mL in 1 VIAL, GLASS (64208-2510-2)		2020-05-27	0000-00-00	No	No	Current
64208-2510-2	64208251002	250 mL in 1 VIAL, GLASS	250 ml					Historical
64208-2510-5	64208251005	1 VIAL, GLASS in 1 CARTON (64208-2510-5) / 500 mL in 1 VIAL, GLASS (64208-2510-6)		2020-05-27	0000-00-00	No	No	Current
64208-2510-6	64208251006	500 mL in 1 VIAL, GLASS	500 ml					Historical