HYPERRAB

Product NDC
13533-618
11-digit product format
135330618
Labeler code
13533
Product ID
13533-618_58aefdbd-27e0-46a7-905e-aefb089a92b2
Type
PLASMA DERIVATIVE
Nonproprietary name
RABIES IMMUNE GLOBULIN (HUMAN)
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
GRIFOLS USA, LLC
Application
BLA101144
Marketing category
BLA
Marketing start
1996-08-14
Substance
HUMAN RABIES VIRUS IMMUNE GLOBULIN
Active strength
150 [iU]/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
HYPERRAB
Brand name suffix
S/D
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HUMAN RABIES VIRUS IMMUNE GLOBULIN150 [iU]/mL

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13533-618-02HYPERRAB S/D1 in 1 CARTONINJECTION122
13533-618-10HYPERRAB S/D1 in 1 CARTONINJECTION122
13533-618-11HYPERRAB S/D10 mL in 1 VIALINJECTION1022
13533-618-20HYPERRAB S/D2 mL in 1 VIAL, GLASSINJECTION222

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13533-618-02ML - Milliliter13533-618a8524617-9ad1-42ec-b6ec-d4c6a71292ce12012-07-24
13533-618-10ML - Milliliter13533-6182ac8d337-4383-4b1f-af44-24deaea5e04e12012-07-24
13533-618-11ML - Milliliter13533-618e9708ab0-2ecd-40f2-b468-00e0350735d512014-10-03
13533-618-20ML - Milliliter13533-61897596185-a6ba-49db-9f19-6a573564d85512014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Human Rabies Virus Immune GlobulinACTIVE INGREDIENT95F619ATQ2HYPERRAB S/D (HUMAN RABIES VIRUS IMMUNE GLOBULIN) INJECTION [GRIFOLS USA, LLC]17
Human Rabies Virus Immune GlobulinACTIVE MOIETY95F619ATQ2HYPERRAB S/D (HUMAN RABIES VIRUS IMMUNE GLOBULIN) INJECTION [GRIFOLS USA, LLC]17
GlycineINACTIVE INGREDIENTTE7660XO1CHYPERRAB S/D (HUMAN RABIES VIRUS IMMUNE GLOBULIN) INJECTION [GRIFOLS USA, LLC]17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13533-618HYPERRAB S/D (RABIES IMMUNE GLOBULIN (HUMAN)) INJECTION [GRIFOLS USA, LLC]22Current NDC, Legacy NDC, 4 package rows20221110_6183eb49-fd6e-4ec2-b41f-8a8dcbd9d4f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1652834HyperRAB 150 UNT/ML in 10 ML InjectionPSN6183eb49-fd6e-4ec2-b41f-8a8dcbd9d4f022
1652830HyperRAB 150 UNT/ML in 2 ML InjectionPSN6183eb49-fd6e-4ec2-b41f-8a8dcbd9d4f022
1652833rabies immune globulin, human 150 UNT/ML in 10 ML InjectionPSN6183eb49-fd6e-4ec2-b41f-8a8dcbd9d4f022
1652827rabies immune globulin, human 150 UNT/ML in 2 ML InjectionPSN6183eb49-fd6e-4ec2-b41f-8a8dcbd9d4f022
165283410 ML rabies immune globulin, human 150 UNT/ML Injection [HyperRAB]SBD6183eb49-fd6e-4ec2-b41f-8a8dcbd9d4f022
16528302 ML rabies immune globulin, human 150 UNT/ML Injection [HyperRAB]SBD6183eb49-fd6e-4ec2-b41f-8a8dcbd9d4f022
165283310 ML rabies immune globulin, human 150 UNT/ML InjectionSCD6183eb49-fd6e-4ec2-b41f-8a8dcbd9d4f022
16528272 ML rabies immune globulin, human 150 UNT/ML InjectionSCD6183eb49-fd6e-4ec2-b41f-8a8dcbd9d4f022
165283410 ML HyperRAB 150 UNT/ML InjectionSY6183eb49-fd6e-4ec2-b41f-8a8dcbd9d4f022
16528302 ML HyperRAB 150 UNT/ML InjectionSY6183eb49-fd6e-4ec2-b41f-8a8dcbd9d4f022
1652830HyperRAB 150 UNT/ML in 2 ML InjectionSY6183eb49-fd6e-4ec2-b41f-8a8dcbd9d4f022
1652834HyperRAB 150 UNT/ML per 10 ML InjectionSY6183eb49-fd6e-4ec2-b41f-8a8dcbd9d4f022
1652833rabies immune globulin, human 150 UNT/ML per 10 ML InjectionSY6183eb49-fd6e-4ec2-b41f-8a8dcbd9d4f022
1652827rabies immune globulin, human 150 UNT/ML per 2 ML InjectionSY6183eb49-fd6e-4ec2-b41f-8a8dcbd9d4f022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13533-618-02135330618021 VIAL, GLASS in 1 CARTON (13533-618-02) / 2 mL in 1 VIAL, GLASS (13533-618-20) 1996-08-140000-00-00NoNoCurrent
13533-618-10135330618101 VIAL in 1 CARTON (13533-618-10) / 10 mL in 1 VIAL (13533-618-11) 1 vial1996-08-140000-00-00NoNoCurrent
13533-618-111353306181110 mL in 1 VIAL10 mlHistorical
13533-618-20135330618202 mL in 1 VIAL, GLASS2 mlHistorical