Albumin (Human)

Product NDC: 68982-623
11-digit product format: 689820623
Labeler code: 68982
Product ID: 68982-623_48ce7e9f-0239-c1b5-ee8e-004cbe7b87ab
Type: PLASMA DERIVATIVE
Nonproprietary name: Albumin Human
Dosage form: SOLUTION
Route: INTRAVENOUS
Labeler: Octapharma USA Inc
Application: BLA125154
Marketing category: BLA
Marketing start: 2006-10-17
Substance: ALBUMIN HUMAN
Active strength: 50 g/1000mL
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	50 g/1000mL

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68982-623-01	Albumin (Human)	100 mL in 1 BOTTLE, GLASS	SOLUTION	100	7
68982-623-02	Albumin (Human)	250 mL in 1 BOTTLE, GLASS	SOLUTION	250	7
68982-623-03	Albumin (Human)	500 mL in 1 BOTTLE, GLASS	SOLUTION	500	7

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68982-623-01	ML - Milliliter	68982-623	083dc15a-4622-4873-a05a-1f824dfc549a	1	2015-09-10
68982-623-02	ML - Milliliter	68982-623	312a56c8-bb68-453c-815f-480c7b5639a1	1	2015-09-10
68982-623-03	ML - Milliliter	68982-623	f5a6a9e9-b968-4334-a9a7-f7f4fda1213e	1	2015-09-10

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
ALBUMIN (HUMAN)	ACTIVE INGREDIENT	ZIF514RVZR	ALBUMIN (HUMAN) (ALBUMIN HUMAN) SOLUTION [OCTAPHARMA USA INC]	1
ALBUMIN (HUMAN)	ACTIVE MOIETY	ZIF514RVZR	ALBUMIN (HUMAN) (ALBUMIN HUMAN) SOLUTION [OCTAPHARMA USA INC]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68982-623	ALBUMIN (HUMAN) (ALBUMIN HUMAN) SOLUTION [OCTAPHARMA USA INC]	7	Current NDC, Legacy NDC, 3 package rows	20200407_bfea0d08-0e7f-a057-7b70-49b909b05a6a.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
1741410	albumin human 5 % in 100 ML Injection	PSN	bfea0d08-0e7f-a057-7b70-49b909b05a6a	7
1741420	albumin human 5 % in 250 ML Injection	PSN	bfea0d08-0e7f-a057-7b70-49b909b05a6a	7
1741423	albumin human 5 % in 500 ML Injection	PSN	bfea0d08-0e7f-a057-7b70-49b909b05a6a	7
1741410	100 ML albumin human, USP 50 MG/ML Injection	SCD	bfea0d08-0e7f-a057-7b70-49b909b05a6a	7
1741420	250 ML albumin human, USP 50 MG/ML Injection	SCD	bfea0d08-0e7f-a057-7b70-49b909b05a6a	7
1741423	500 ML albumin human, USP 50 MG/ML Injection	SCD	bfea0d08-0e7f-a057-7b70-49b909b05a6a	7
1741420	albumin human 12.5 GM per 250 ML Injection	SY	bfea0d08-0e7f-a057-7b70-49b909b05a6a	7
1741423	albumin human 25 GM per 500 ML Injection	SY	bfea0d08-0e7f-a057-7b70-49b909b05a6a	7
1741410	albumin human 5 % per 100 ML Injection	SY	bfea0d08-0e7f-a057-7b70-49b909b05a6a	7
1741420	albumin human 5 % per 250 ML Injection	SY	bfea0d08-0e7f-a057-7b70-49b909b05a6a	7
1741423	albumin human 5 % per 500 ML Injection	SY	bfea0d08-0e7f-a057-7b70-49b909b05a6a	7
1741410	albumin human 5 GM per 100 ML Injection	SY	bfea0d08-0e7f-a057-7b70-49b909b05a6a	7

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68982-623-01	68982062301	100 mL in 1 BOTTLE, GLASS (68982-623-01)	100 ml	2006-10-17	0000-00-00	No	No	Current
68982-623-02	68982062302	250 mL in 1 BOTTLE, GLASS (68982-623-02)	250 ml	2006-10-17	0000-00-00	No	No	Current
68982-623-03	68982062303	500 mL in 1 BOTTLE, GLASS (68982-623-03)	500 ml	2006-10-17	0000-00-00	No	No	Current