FLEBOGAMMA DIF

Product NDC: 61953-0005
Requested package NDC: 61953-0005-2
11-digit product format: 619530005
Labeler code: 61953
Product ID: 61953-0005_2dc9ff6f-7460-4520-a5fa-e89d053ae8b0
Type: PLASMA DERIVATIVE
Nonproprietary name: IMMUNE GLOBULIN INTRAVENOUS (HUMAN)
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: GRIFOLS USA, LLC
Application: BLA125077
Marketing category: BLA
Marketing start: 2010-07-27
Marketing end: 0000-00-00
Substance: HUMAN IMMUNOGLOBULIN G
Active strength: 5 g/50mL
Pharmacologic classes: Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	61953-0005	61953-0005-2	D	Discontinued by firm		2026-07-31

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61953-0005-1	ML - Milliliter	61953-0005	0cc4ecec-634d-4ec7-b64e-3b75241bd15d	1	2012-07-24
61953-0005-2	ML - Milliliter	61953-0005	ca65abda-0cf2-4708-a8f2-6b3405be564f	1	2012-07-24
61953-0005-3	ML - Milliliter	61953-0005	c2e5a140-6dd0-46a4-8cc6-339345c775b8	1	2012-07-24
61953-0005-4	ML - Milliliter	61953-0005	da98d036-7c20-41bb-acdb-72abce3c9de9	1	2014-01-04
61953-0005-5	ML - Milliliter	61953-0005	81c350d8-5b13-47c2-8945-63bc7515e83d	1	2014-01-04
61953-0005-6	ML - Milliliter	61953-0005	96558ba9-0b04-4ada-bee2-5ffd78485575	1	2014-01-04

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Human Immunoglobulin G	ACTIVE INGREDIENT	66Y330CJHS	FLEBOGAMMA DIF (HUMAN IMMUNOGLOBULIN G) INJECTION, SOLUTION [GRIFOLS USA, LLC]	13
Human Immunoglobulin G	ACTIVE MOIETY	66Y330CJHS	FLEBOGAMMA DIF (HUMAN IMMUNOGLOBULIN G) INJECTION, SOLUTION [GRIFOLS USA, LLC]	13
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	FLEBOGAMMA DIF (HUMAN IMMUNOGLOBULIN G) INJECTION, SOLUTION [GRIFOLS USA, LLC]	13
sorbitol	INACTIVE INGREDIENT	506T60A25R	FLEBOGAMMA DIF (HUMAN IMMUNOGLOBULIN G) INJECTION, SOLUTION [GRIFOLS USA, LLC]	13

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125077	Flebogamma 5%, Flebogamma 5% Dif	Immune Globulin Intravenous (Human)	351(a)	Disc	2026-06-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
66Y330CJHS	HUMAN IMMUNOGLOBULIN G	308067-58-5	HUMAN IMMUNOGLOBULIN G

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61953-0005-2	61953000502	1 VIAL in 1 CARTON (61953-0005-2) > 100 mL in 1 VIAL (61953-0005-5)	1 vial	2010-07-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FLEBOGAMMA DIF	GRIFOLS USA, LLC \| Instituto Grifols, S.A. \| GRIFOLS WORLDWIDE OPERATIONS LIMITED	2022-12-05	PLASMA DERIVATIVE	26