FDA.reportPublic FDA data

MICRhoGAM Ultra-Filtered PLUS

Product NDC
0562-7806
Requested package NDC
0562-7806-01
11-digit product format
005627806
Labeler code
0562
Product ID
0562-7806_fd670401-c911-45aa-a41f-b243d30800c1
Type
PLASMA DERIVATIVE
Nonproprietary name
HUMAN RHO(D) IMMUNE GLOBULIN
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Kedrion Biopharma Inc
Application
BLA103777
Marketing category
BLA
Marketing start
2007-03-09
Marketing end
0000-00-00
Substance
HUMAN RHO(D) IMMUNE GLOBULIN
Active strength
50 ug/1
Pharmacologic classes
Endogenous Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]
NDC exclude flag
No
Listing certified through
2024-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0562-78060562-7806-01DDiscontinued by firm2026-08-03

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 · 12 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2022-08-30 03:57 UTC · source 2022-08-29IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0562-7806-012024-12-30These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-012024-12-30These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-052024-12-30These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-052024-12-30These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-252024-12-30These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-252024-12-30These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-012024-08-02These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-012024-08-02These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-052024-08-02These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-052024-08-02These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-252024-08-02These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-252024-08-02These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-012024-07-30These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-012024-07-30These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-052024-07-30These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-052024-07-30These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-252024-07-30These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-252024-07-30These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-012024-01-30These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-012024-01-30These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-052024-01-30These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-052024-01-30These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-252024-01-30These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-252024-01-30These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-012022-12-16These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-012022-12-16These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-052022-12-16These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-052022-12-16These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-252022-12-16These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-252022-12-16These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-012022-07-29These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-012022-07-29These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-052022-07-29These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-052022-07-29These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-252022-07-29These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-252022-07-29These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0562-7806-00MICRhoGAM Ultra-Filtered PLUS1 in 1 POUCHINJECTION, SOLUTION119
0562-7806-01MICRhoGAM Ultra-Filtered PLUS1 in 1 CARTONINJECTION, SOLUTION119
0562-7806-05MICRhoGAM Ultra-Filtered PLUS5 in 1 CARTONINJECTION, SOLUTION519
0562-7806-25MICRhoGAM Ultra-Filtered PLUS25 in 1 CARTONINJECTION, SOLUTION2519

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0562-7806-00EA - Each0562-78062053adf0-ccf1-426a-ab11-31264df1859812014-02-04
0562-7806-01EA - Each0562-780642899d5c-8323-444c-974f-c291b4721fed12012-07-24
0562-7806-05EA - Each0562-7806ae316482-2490-47ee-8b02-8da135b2703712012-07-24
0562-7806-25EA - Each0562-7806ecb11afd-ba62-4851-9f38-7c68c234368212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HUMAN RHO(D) IMMUNE GLOBULINACTIVE INGREDIENT48W7181FLPRHOGAM ULTRA-FILTERED PLUS (HUMAN RHO(D) IMMUNE GLOBULIN) INJECTION, SOLUTION MICRHOGAM ULTRA-FILTERED PLUS (HUMAN RHO(D) IMMUNE GLOBULIN) INJECTION, SOLUTION [KEDRION MELVILLE, INC.]8
HUMAN RHO(D) IMMUNE GLOBULINACTIVE MOIETY48W7181FLPRHOGAM ULTRA-FILTERED PLUS (HUMAN RHO(D) IMMUNE GLOBULIN) INJECTION, SOLUTION MICRHOGAM ULTRA-FILTERED PLUS (HUMAN RHO(D) IMMUNE GLOBULIN) INJECTION, SOLUTION [KEDRION MELVILLE, INC.]8
GLYCINEINACTIVE INGREDIENTTE7660XO1CRHOGAM ULTRA-FILTERED PLUS (HUMAN RHO(D) IMMUNE GLOBULIN) INJECTION, SOLUTION MICRHOGAM ULTRA-FILTERED PLUS (HUMAN RHO(D) IMMUNE GLOBULIN) INJECTION, SOLUTION [KEDRION MELVILLE, INC.]8
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HRHOGAM ULTRA-FILTERED PLUS (HUMAN RHO(D) IMMUNE GLOBULIN) INJECTION, SOLUTION MICRHOGAM ULTRA-FILTERED PLUS (HUMAN RHO(D) IMMUNE GLOBULIN) INJECTION, SOLUTION [KEDRION MELVILLE, INC.]8
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XRHOGAM ULTRA-FILTERED PLUS (HUMAN RHO(D) IMMUNE GLOBULIN) INJECTION, SOLUTION MICRHOGAM ULTRA-FILTERED PLUS (HUMAN RHO(D) IMMUNE GLOBULIN) INJECTION, SOLUTION [KEDRION MELVILLE, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0562-7806RHOGAM ULTRA-FILTERED PLUS (HUMAN RHO(D) IMMUNE GLOBULIN) INJECTION, SOLUTION MICRHOGAM ULTRA-FILTERED PLUS (HUMAN RHO(D) IMMUNE GLOBULIN) INJECTION, SOLUTION [KEDRION BIOPHARMA INC]18Legacy NDC, 4 package rows20250101_d87e4d0b-2442-4135-b3f9-5c4f74845b87.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103777Micrhogam, RhogamRho(D) Immune Globulin (Human)351(a)Disc2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
731380MICRhoGAM 250 UNT (50 MCG) Prefilled SyringePSNd87e4d0b-2442-4135-b3f9-5c4f74845b8719
731381rho(D) immune globulin, human 1500 UNT (300 MCG) Prefilled SyringePSNd87e4d0b-2442-4135-b3f9-5c4f74845b8719
1790353rho(D) immune globulin, human 250 UNT (50 MCG) Prefilled SyringePSNd87e4d0b-2442-4135-b3f9-5c4f74845b8719
731383RhoGAM 1500 UNT (300 MCG) Prefilled SyringePSNd87e4d0b-2442-4135-b3f9-5c4f74845b8719
731383Rho(D) immune globulin, human 1500 UNT Prefilled Syringe [RhoGAM]SBDd87e4d0b-2442-4135-b3f9-5c4f74845b8719
731380Rho(D) immune globulin, human 250 UNT Prefilled Syringe [MICRhoGAM]SBDd87e4d0b-2442-4135-b3f9-5c4f74845b8719
731381Rho(D) immune globulin, human 1500 UNT Prefilled SyringeSCDd87e4d0b-2442-4135-b3f9-5c4f74845b8719
1790353Rho(D) immune globulin, human 250 UNT Prefilled SyringeSCDd87e4d0b-2442-4135-b3f9-5c4f74845b8719
731380MICRhoGAM 250 UNT Prefilled SyringeSYd87e4d0b-2442-4135-b3f9-5c4f74845b8719
731383RhoGAM 1500 UNT Prefilled SyringeSYd87e4d0b-2442-4135-b3f9-5c4f74845b8719

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0562-7806-01005627806011 POUCH in 1 CARTON (0562-7806-01) > 1 INJECTION, SOLUTION in 1 POUCH (0562-7806-00) 1 pouch2007-03-090000-00-00NoNoCurrent