FDA.reportPublic FDA data

RhoGAM Ultra-Filtered PLUS

Product NDC
0562-7805
11-digit product format
005627805
Labeler code
0562
Product ID
0562-7805_7ccbaf67-ab6a-490a-9b63-598d75a7afca
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
Substance
HUMAN RHO(D) IMMUNE GLOBULIN
Active strength
300 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
RhoGAM Ultra-Filtered PLUS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HUMAN RHO(D) IMMUNE GLOBULIN300 ug/1

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0562-7805-012024-08-02C16284748780-1e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4eThese 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
0562-7805-012024-08-02C16284748780-1e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4eThese 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
0562-7805-052024-08-02C16284748780-1e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4eThese 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
0562-7805-052024-08-02C16284748780-1e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4eThese 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
0562-7805-252024-08-02C16284748780-1e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4eThese 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
0562-7805-252024-08-02C16284748780-1e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4eThese 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
0562-7805-012024-07-30C16284748780-1e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4eThese 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
0562-7805-012024-07-30C16284748780-1e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4eThese 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
0562-7805-052024-07-30C16284748780-1e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4eThese 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
0562-7805-052024-07-30C16284748780-1e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4eThese 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
0562-7805-252024-07-30C16284748780-1e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4eThese 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
0562-7805-252024-07-30C16284748780-1e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4eThese 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
0562-7805-012024-01-30C16284748780-1e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4eThese 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
0562-7805-012024-01-30C16284748780-1e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4eThese 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
0562-7805-052024-01-30C16284748780-1e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4eThese 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
0562-7805-052024-01-30C16284748780-1e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4eThese 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
0562-7805-252024-01-30C16284748780-1e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4eThese 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
0562-7805-252024-01-30C16284748780-1e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4eThese 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
0562-7805-012022-12-16C16284748780-1e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4eThese 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
0562-7805-012022-12-16C16284748780-1e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4eThese 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
0562-7805-052022-12-16C16284748780-1e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4eThese 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
0562-7805-052022-12-16C16284748780-1e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4eThese 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
0562-7805-252022-12-16C16284748780-1e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4eThese 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
0562-7805-252022-12-16C16284748780-1e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4eThese 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
0562-7805-012022-07-29C16284748780-1e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4eThese 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
0562-7805-012022-07-29C16284748780-1e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4eThese 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
0562-7805-052022-07-29C16284748780-1e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4eThese 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
0562-7805-052022-07-29C16284748780-1e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4eThese 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
0562-7805-252022-07-29C16284748780-1e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4eThese 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
0562-7805-252022-07-29C16284748780-1e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4eThese 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
0562-7805-00RhoGAM Ultra-Filtered PLUS1 in 1 POUCHINJECTION, SOLUTION119
0562-7805-01RhoGAM Ultra-Filtered PLUS1 in 1 CARTONINJECTION, SOLUTION119
0562-7805-05RhoGAM Ultra-Filtered PLUS5 in 1 CARTONINJECTION, SOLUTION519
0562-7805-25RhoGAM Ultra-Filtered PLUS25 in 1 CARTONINJECTION, SOLUTION2519

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0562-7805-00EA - Each0562-780596ec94f7-c1b7-452b-bd09-ff95c8b66c5e12014-02-04
0562-7805-01EA - Each0562-78050c7a3c1e-d4a9-413f-913f-71725fc02c8b12012-07-24
0562-7805-05EA - Each0562-7805d6bdcf5a-ffad-4464-9123-b340a7c9540912012-07-24
0562-7805-25EA - Each0562-7805db5d1ee5-4e51-40a9-b1b5-d4642a19992a12012-07-24

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
0562-7805RHOGAM ULTRA-FILTERED PLUS (HUMAN RHO(D) IMMUNE GLOBULIN) INJECTION, SOLUTION MICRHOGAM ULTRA-FILTERED PLUS (HUMAN RHO(D) IMMUNE GLOBULIN) INJECTION, SOLUTION [KEDRION BIOPHARMA INC]18Current NDC, Legacy NDC, 4 package rows20250101_d87e4d0b-2442-4135-b3f9-5c4f74845b87.zip

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
0562-7805-00005627805001 in 1 POUCHHistorical
0562-7805-01005627805011 POUCH in 1 CARTON (0562-7805-01) / 1 INJECTION, SOLUTION in 1 POUCH (0562-7805-00) 1 pouch2007-03-090000-00-00NoNoCurrent
0562-7805-05005627805055 POUCH in 1 CARTON (0562-7805-05) / 1 INJECTION, SOLUTION in 1 POUCH (0562-7805-00) 5 pouch2007-03-090000-00-00NoNoCurrent
0562-7805-250056278052525 POUCH in 1 CARTON (0562-7805-25) / 1 INJECTION, SOLUTION in 1 POUCH (0562-7805-00) 25 pouch2007-03-090000-00-00NoNoCurrent