FDA.reportPublic FDA data

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#

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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61953-0005DDiscontinued by firm2026-07-31
excluded packagepackage61953-000561953-0005-1DDiscontinued by firm2026-07-31
excluded packagepackage61953-000561953-0005-2DDiscontinued by firm2026-07-31
excluded packagepackage61953-000561953-0005-3DDiscontinued by firm2026-07-31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61953-0005-1ML - Milliliter61953-00050cc4ecec-634d-4ec7-b64e-3b75241bd15d12012-07-24
61953-0005-2ML - Milliliter61953-0005ca65abda-0cf2-4708-a8f2-6b3405be564f12012-07-24
61953-0005-3ML - Milliliter61953-0005c2e5a140-6dd0-46a4-8cc6-339345c775b812012-07-24
61953-0005-4ML - Milliliter61953-0005da98d036-7c20-41bb-acdb-72abce3c9de912014-01-04
61953-0005-5ML - Milliliter61953-000581c350d8-5b13-47c2-8945-63bc7515e83d12014-01-04
61953-0005-6ML - Milliliter61953-000596558ba9-0b04-4ada-bee2-5ffd7848557512014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Human Immunoglobulin GACTIVE INGREDIENT66Y330CJHSFLEBOGAMMA DIF (HUMAN IMMUNOGLOBULIN G) INJECTION, SOLUTION [GRIFOLS USA, LLC]13
Human Immunoglobulin GACTIVE MOIETY66Y330CJHSFLEBOGAMMA DIF (HUMAN IMMUNOGLOBULIN G) INJECTION, SOLUTION [GRIFOLS USA, LLC]13
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AFLEBOGAMMA DIF (HUMAN IMMUNOGLOBULIN G) INJECTION, SOLUTION [GRIFOLS USA, LLC]13
sorbitolINACTIVE INGREDIENT506T60A25RFLEBOGAMMA DIF (HUMAN IMMUNOGLOBULIN G) INJECTION, SOLUTION [GRIFOLS USA, LLC]13

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125077Flebogamma 5%, Flebogamma 5% DifImmune Globulin Intravenous (Human)351(a)Disc2026-06-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61953-0005-1619530005011 VIAL in 1 CARTON (61953-0005-1) > 50 mL in 1 VIAL (61953-0005-4) 1 vial2010-07-270000-00-00NoNoCurrent
61953-0005-2619530005021 VIAL in 1 CARTON (61953-0005-2) > 100 mL in 1 VIAL (61953-0005-5) 1 vial2010-07-270000-00-00NoNoCurrent
61953-0005-3619530005031 VIAL in 1 CARTON (61953-0005-3) > 200 mL in 1 VIAL (61953-0005-6) 1 vial2010-07-270000-00-00NoNoCurrent