ALBUMINEX

Product NDC: 64208-2512
11-digit product format: 642082512
Labeler code: 64208
Product ID: 64208-2512_85f1cecd-a23d-498f-adfb-0a09feed1994
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: .25 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#

Finished product: Yes
Brand name base: ALBUMINEX
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALBUMIN HUMAN	.25 g/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ZIF514RVZR	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2054168	Internal RxNorm lookup
2054170	Internal RxNorm lookup
2054173	Internal RxNorm lookup
2054174	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
167f48d0-8ae5-4f7e-b050-9673dad78acc	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
be52172d-e80b-4aac-aa81-254100bce67f	Product name	9	20260304
c4fcacbc-a699-410c-905b-642c4d134e72	Product name	1	20250616
ad3381c5-7539-4a18-83b7-e7382b118d04	Product name	1	20231117
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
60a22813-7270-4733-af61-30636bce9f0f	Product name	4	20180820
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
0179c4ba-fb03-4931-875d-b4f1ba528029	Product name	1	20160107
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
9ff92ef8-2da9-4645-bbf8-642e7eb0d754	Product name	1	20150812
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64208-2512-3	ALBUMINEX	1 in 1 CARTON	SOLUTION	1		8
64208-2512-4	ALBUMINEX	50 mL in 1 VIAL, GLASS	SOLUTION	50		8
64208-2512-7	ALBUMINEX	1 in 1 CARTON	SOLUTION	1		8
64208-2512-8	ALBUMINEX	100 mL in 1 VIAL, GLASS	SOLUTION	100		8
64208-2512-4	BEIZRAY	50 mL in 1 VIAL, GLASS	SOLUTION	50 mL	0.25 g in 1mL	4
64208-2512-4	BEIZRAY	50 mL in 1 VIAL, GLASS	SOLUTION	50 mL	0.25 g in 1mL	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64208-2512-3	ML - Milliliter	64208-2512	c86cf615-9a91-4a57-83dc-936eceb78fb2	1	2018-12-13
64208-2512-4	ML - Milliliter	64208-2512	8e6b36bd-bfff-4d22-8d21-be42c8612925	1	2019-06-19
64208-2512-7	ML - Milliliter	64208-2512	f9006057-f212-4168-98a9-17e10e725ec3	1	2018-12-13
64208-2512-8	ML - Milliliter	64208-2512	02da426e-e1a7-46a2-88b9-622b29bfd20e	1	2019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64208-2512	ALBUMINEX (ALBUMIN HUMAN) SOLUTION [BPL]	8	Current NDC, Legacy NDC, 4 package rows	20250109_167f48d0-8ae5-4f7e-b050-9673dad78acc.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ALBUMINEX	ALBUMIN HUMAN	BPL	8428d373-f4b1-4e3b-bb19-ea89048f7c79	2024-12-31	Warnings, Adverse reactions	Exact identifier application number: BLA125644
ALBUMINEX	ALBUMIN HUMAN	BPL	167f48d0-8ae5-4f7e-b050-9673dad78acc	2024-12-31	Warnings, Adverse reactions	Exact identifier application number: BLA125644 ndc (product): 64208-2512

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125644	Albuminex	Albumin (Human)-kjda	351(a)	Rx	2026-06-01

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2054173	albumin human-kjda 25 % in 100 ML Injection	PSN	167f48d0-8ae5-4f7e-b050-9673dad78acc	8
2054168	albumin human-kjda 25 % in 50 ML Injection	PSN	167f48d0-8ae5-4f7e-b050-9673dad78acc	8
2054174	ALBUMINEX 25 % in 100 ML Injection	PSN	167f48d0-8ae5-4f7e-b050-9673dad78acc	8
2054170	ALBUMINEX 25 % in 50 ML Injection	PSN	167f48d0-8ae5-4f7e-b050-9673dad78acc	8
2054174	100 ML albumin human-kjda 250 MG/ML Injection [Albuminex]	SBD	167f48d0-8ae5-4f7e-b050-9673dad78acc	8
2054170	50 ML albumin human-kjda 250 MG/ML Injection [Albuminex]	SBD	167f48d0-8ae5-4f7e-b050-9673dad78acc	8
2054173	100 ML albumin human-kjda 250 MG/ML Injection	SCD	167f48d0-8ae5-4f7e-b050-9673dad78acc	8
2054168	50 ML albumin human-kjda 250 MG/ML Injection	SCD	167f48d0-8ae5-4f7e-b050-9673dad78acc	8
2054173	albumin human-kjda 25 % per 100 ML Injection	SY	167f48d0-8ae5-4f7e-b050-9673dad78acc	8
2054168	albumin human-kjda 25 % per 50 ML Injection	SY	167f48d0-8ae5-4f7e-b050-9673dad78acc	8
2054173	albumin human-kjda 250 MG/ML per 100 ML Injection	SY	167f48d0-8ae5-4f7e-b050-9673dad78acc	8
2054168	albumin human-kjda 250 MG/ML per 50 ML Injection	SY	167f48d0-8ae5-4f7e-b050-9673dad78acc	8
2054174	Albuminex 25 % per 100 ML Injection	SY	167f48d0-8ae5-4f7e-b050-9673dad78acc	8
2054170	Albuminex 25 % per 50 ML Injection	SY	167f48d0-8ae5-4f7e-b050-9673dad78acc	8
2054174	Albuminex 250 MG/ML per 100 ML Injection	SY	167f48d0-8ae5-4f7e-b050-9673dad78acc	8
2054170	Albuminex 250 MG/ML per 50 ML Injection	SY	167f48d0-8ae5-4f7e-b050-9673dad78acc	8
2723664	{1 (4 ML docetaxel 20 MG/ML Injection [Beizray]) / 1 (50 ML albumin human-kjda 250 MG/ML Injection [Albuminex]) } Pack [Beizray 80 MG Kit]	BPCK	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2723666	{2 (4 ML docetaxel 20 MG/ML Injection [Beizray]) / 1 (50 ML albumin human-kjda 250 MG/ML Injection [Albuminex]) } Pack [Beizray 160 MG Kit]	BPCK	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2723663	{1 (4 ML docetaxel 20 MG/ML Injection) / 1 (50 ML albumin human-kjda 250 MG/ML Injection) } Pack	GPCK	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2723665	{2 (4 ML docetaxel 20 MG/ML Injection) / 1 (50 ML albumin human-kjda 250 MG/ML Injection) } Pack	GPCK	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2054168	albumin human-kjda 25 % in 50 ML Injection	PSN	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2054170	ALBUMINEX 25 % in 50 ML Injection	PSN	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2723666	BEIZRAY 160 MG Kit	PSN	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2728902	BEIZRAY 20 MG in 1 ML Injection	PSN	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2697044	BEIZRAY 80 MG in 4 ML Injection	PSN	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2723664	BEIZRAY 80 MG Kit	PSN	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2723665	DOCEtaxel 160 MG Kit	PSN	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
1860480	DOCEtaxel 20 MG in 1 ML Injection	PSN	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
1860485	DOCEtaxel 80 MG in 4 ML Injection	PSN	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2723663	DOCEtaxel 80 MG Kit	PSN	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2728902	1 ML docetaxel 20 MG/ML Injection [Beizray]	SBD	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2697044	4 ML docetaxel 20 MG/ML Injection [Beizray]	SBD	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2054170	50 ML albumin human-kjda 250 MG/ML Injection [Albuminex]	SBD	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
1860480	1 ML docetaxel 20 MG/ML Injection	SCD	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
1860485	4 ML docetaxel 20 MG/ML Injection	SCD	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2054168	50 ML albumin human-kjda 250 MG/ML Injection	SCD	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2054168	albumin human-kjda 25 % per 50 ML Injection	SY	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2054168	albumin human-kjda 250 MG/ML per 50 ML Injection	SY	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2054170	Albuminex 25 % per 50 ML Injection	SY	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2054170	Albuminex 250 MG/ML per 50 ML Injection	SY	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2723666	Beizray 160 MG Kit	SY	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2728902	Beizray 20 MG per 1 ML Injection	SY	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2723664	Beizray 80 MG Kit	SY	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2697044	Beizray 80 MG per 4 ML Injection	SY	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2723665	docetaxel 160 MG Kit	SY	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
1860480	docetaxel 20 MG per 1 ML Injection	SY	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2723663	docetaxel 80 MG Kit	SY	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
1860485	docetaxel 80 MG per 4 ML Injection	SY	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64208-2512-3	64208251203	1 VIAL, GLASS in 1 CARTON (64208-2512-3) / 50 mL in 1 VIAL, GLASS (64208-2512-4)		2020-05-27	0000-00-00	No	No	Current
64208-2512-4	64208251204	50 mL in 1 VIAL, GLASS	50 ml					Historical
64208-2512-7	64208251207	1 VIAL, GLASS in 1 CARTON (64208-2512-7) / 100 mL in 1 VIAL, GLASS (64208-2512-8)		2020-05-27	0000-00-00	No	No	Current
64208-2512-8	64208251208	100 mL in 1 VIAL, GLASS	100 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BEIZRAY	Zydus Pharmaceuticals USA Inc. \| Kindos Pharmaceuticals Co., Ltd. \| Ningbo Shuangcheng Pharmaceutical Co., Ltd \| Bio Products Laboratory Ltd.	2025-12-17	HUMAN PRESCRIPTION DRUG LABEL	4
ALBUMINEX	BPL	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	8