FDA.reportPublic FDA data

HyperRAB

Product NDC
13533-318
11-digit product format
135330318
Labeler code
13533
Product ID
13533-318_880a0273-4487-4f86-a949-2c91898bdd78
Type
PLASMA DERIVATIVE
Nonproprietary name
Rabies Immune Globulin (Human)
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; INTRAMUSCULAR
Labeler
GRIFOLS USA, LLC
Application
BLA101144
Marketing category
BLA
Marketing start
1974-06-12
Substance
HUMAN RABIES VIRUS IMMUNE GLOBULIN
Active strength
300 [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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HUMAN RABIES VIRUS IMMUNE GLOBULIN300 [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
13533-318-01HyperRAB1 in 1 CARTONINJECTION, SOLUTION110
13533-318-03HyperRAB1 in 1 CARTONINJECTION, SOLUTION110
13533-318-05HyperRAB1 in 1 CARTONINJECTION, SOLUTION110
13533-318-10HyperRAB1 mL in 1 VIALINJECTION, SOLUTION110
13533-318-30HyperRAB3 mL in 1 VIALINJECTION, SOLUTION310
13533-318-50HyperRAB5 mL in 1 VIALINJECTION, SOLUTION510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13533-318-01ML - Milliliter13533-3188426b48d-4317-4a11-9be5-9997ab48f25712018-05-09
13533-318-03ML - Milliliter13533-3189b106187-89ed-4063-ac8f-1c077b19d5a812020-04-20
13533-318-05ML - Milliliter13533-318fc20e906-e965-4de2-8ed6-a54986b2979212018-05-09
13533-318-10ML - Milliliter13533-3183c760681-02b7-4ef0-9a81-39aaebe9573012018-05-09
13533-318-30ML - Milliliter13533-3183b28c5aa-c586-4861-bb24-26f2aba6713312020-04-20
13533-318-50ML - Milliliter13533-31826362cc6-772c-40ac-b250-89da0081da2e12018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13533-318HYPERRAB (RABIES IMMUNE GLOBULIN (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC]10Current NDC, Legacy NDC, 6 package rows20241006_f82880b8-998c-4659-8f20-6dcc81f258e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2043312HyperRAB 1500 UNT in 5 mL InjectionPSNf82880b8-998c-4659-8f20-6dcc81f258e910
2043308HyperRAB 300 UNT in 1 mL InjectionPSNf82880b8-998c-4659-8f20-6dcc81f258e910
2267418HyperRAB 900 UNT in 3 mL InjectionPSNf82880b8-998c-4659-8f20-6dcc81f258e910
2043311rabies immune globulin, human 1500 UNT in 5 mL InjectionPSNf82880b8-998c-4659-8f20-6dcc81f258e910
2043306rabies immune globulin, human 300 UNT in 1 mL InjectionPSNf82880b8-998c-4659-8f20-6dcc81f258e910
2267417rabies immune globulin, human 900 UNT in 3 mL InjectionPSNf82880b8-998c-4659-8f20-6dcc81f258e910
20433081 ML rabies immune globulin, human 300 UNT/ML Injection [HyperRAB]SBDf82880b8-998c-4659-8f20-6dcc81f258e910
22674183 ML rabies immune globulin, human 300 UNT/ML Injection [HyperRAB]SBDf82880b8-998c-4659-8f20-6dcc81f258e910
20433125 ML rabies immune globulin, human 300 UNT/ML Injection [HyperRAB]SBDf82880b8-998c-4659-8f20-6dcc81f258e910
20433061 ML rabies immune globulin, human 300 UNT/ML InjectionSCDf82880b8-998c-4659-8f20-6dcc81f258e910
22674173 ML rabies immune globulin, human 300 UNT/ML InjectionSCDf82880b8-998c-4659-8f20-6dcc81f258e910
20433115 ML rabies immune globulin, human 300 UNT/ML InjectionSCDf82880b8-998c-4659-8f20-6dcc81f258e910
20433081 ML HyperRAB 300 UNT/ML InjectionSYf82880b8-998c-4659-8f20-6dcc81f258e910
22674183 ML HyperRAB 300 UNT/ML InjectionSYf82880b8-998c-4659-8f20-6dcc81f258e910
20433125 ML HyperRAB 300 UNT/ML InjectionSYf82880b8-998c-4659-8f20-6dcc81f258e910
2043312HyperRAB 1500 UNT per 5 ML InjectionSYf82880b8-998c-4659-8f20-6dcc81f258e910
2043308HyperRAB 300 UNT per 1 ML InjectionSYf82880b8-998c-4659-8f20-6dcc81f258e910
2267418HyperRAB 900 UNT per 3 ML InjectionSYf82880b8-998c-4659-8f20-6dcc81f258e910
2043311rabies immune globulin, human 1500 UNT per 5 ML InjectionSYf82880b8-998c-4659-8f20-6dcc81f258e910
2043306rabies immune globulin, human 300 UNT per 1 ML InjectionSYf82880b8-998c-4659-8f20-6dcc81f258e910
2267417rabies immune globulin, human 900 UNT per 3 ML InjectionSYf82880b8-998c-4659-8f20-6dcc81f258e910

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13533-318-01135330318011 VIAL in 1 CARTON (13533-318-01) / 1 mL in 1 VIAL (13533-318-10) 1 vial1974-06-120000-00-00NoNoCurrent
13533-318-03135330318031 VIAL in 1 CARTON (13533-318-03) / 3 mL in 1 VIAL (13533-318-30) 1 vial1974-06-120000-00-00NoNoCurrent
13533-318-05135330318051 VIAL in 1 CARTON (13533-318-05) / 5 mL in 1 VIAL (13533-318-50) 1 vial1974-06-120000-00-00NoNoCurrent
13533-318-10135330318101 mL in 1 VIAL1 mlHistorical
13533-318-30135330318303 mL in 1 VIAL3 mlHistorical
13533-318-50135330318505 mL in 1 VIAL5 mlHistorical