FLEBOGAMMA DIF

Product NDC: 61953-0005
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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61953-0005		D	Discontinued by firm	2026-10-05
excluded package	package	61953-0005	61953-0005-1	D	Discontinued by firm	2026-10-05
excluded package	package	61953-0005	61953-0005-2	D	Discontinued by firm	2026-10-05
excluded package	package	61953-0005	61953-0005-3	D	Discontinued by firm	2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61953-0005-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61953-0005-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61953-0005-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61953-0005-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61953-0005-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61953-0005-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61953-0005-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61953-0005-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61953-0005-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61953-0005-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61953-0005-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61953-0005-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61953-0005-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61953-0005-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61953-0005-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61953-0005-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61953-0005-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61953-0005-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61953-0005-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61953-0005-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61953-0005-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61953-0005-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61953-0005-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61953-0005-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61953-0005-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61953-0005-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61953-0005-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61953-0005-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61953-0005-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61953-0005-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61953-0005-2	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61953-0005-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61953-0005-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61953-0005-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61953-0005-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61953-0005-1	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

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

DailyMed Socrata Ingredients#

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

Purple Book Biologic Products#

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	2026-09-01

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61953-0005-1	61953000501	1 VIAL in 1 CARTON (61953-0005-1) > 50 mL in 1 VIAL (61953-0005-4)	1 vial	2010-07-27	0000-00-00	No	No	Current
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
61953-0005-3	61953000503	1 VIAL in 1 CARTON (61953-0005-3) > 200 mL in 1 VIAL (61953-0005-6)	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