FDA.reportPublic FDA data

HYPERHEP B

Product NDC
13533-636
11-digit product format
135330636
Labeler code
13533
Product ID
13533-636_07a45b19-8ed3-48e2-9c0f-9620437fd452
Type
PLASMA DERIVATIVE
Nonproprietary name
HEPATITIS B IMMUNE GLOBULIN (HUMAN)
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
GRIFOLS USA, LLC
Application
BLA101146
Marketing category
BLA
Marketing start
1996-10-09
Substance
HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN
Active strength
220 [iU]/mL
Pharmacologic classes
Human Immunoglobulin [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE], Virus Neutralization [MoA], Virus-specific Hyperimmune Globulins [EXT]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
HYPERHEP B
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN220 [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
13533-636-01HYPERHEP B1 in 1 CARTONINJECTION126
13533-636-02HYPERHEP B1 in 1 CARTONINJECTION126
13533-636-03HYPERHEP B1 in 1 CARTONINJECTION126
13533-636-05HYPERHEP B1 in 1 CARTONINJECTION126
13533-636-10HYPERHEP B1 mL in 1 VIAL, GLASSINJECTION126
13533-636-20HYPERHEP B1 mL in 1 SYRINGE, GLASSINJECTION126
13533-636-30HYPERHEP B0.5 mL in 1 SYRINGE, GLASSINJECTION0.526
13533-636-50HYPERHEP B5 mL in 1 VIAL, GLASSINJECTION526

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13533-636-01ML - Milliliter13533-6360f0cf9b8-7a6a-4d52-bcca-74b071a1a8ef12013-02-13
13533-636-02ML - Milliliter13533-63685a8f3c8-6673-47c2-af7c-92a763a23b6712012-07-24
13533-636-03ML - Milliliter13533-636244c9c74-7758-42a8-8420-490cdf24362f12012-07-24
13533-636-05ML - Milliliter13533-63620ea87c0-3b0b-4270-b11c-f23a360d03ac12012-07-24
13533-636-10ML - Milliliter13533-6360367b921-2e73-4232-a69a-189af775391712015-10-02
13533-636-20ML - Milliliter13533-63675dbb46e-137c-4fa8-8a27-a64f10f1b92112014-10-03
13533-636-30ML - Milliliter13533-636fe7bca80-ae82-4cbf-8469-edc83424699812014-10-03
13533-636-50ML - Milliliter13533-6367447a359-789f-435c-a393-daf51915352412014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Human Hepatitis B Virus Immune GlobulinACTIVE INGREDIENTXII270YC6MHYPERHEP B S/D (HEPATITIS B IMMUNE GLOBULIN (HUMAN)) INJECTION [GRIFOLS USA, LLC]12
Human Hepatitis B Virus Immune GlobulinACTIVE MOIETYXII270YC6MHYPERHEP B S/D (HEPATITIS B IMMUNE GLOBULIN (HUMAN)) INJECTION [GRIFOLS USA, LLC]12
GlycineINACTIVE INGREDIENTTE7660XO1CHYPERHEP B S/D (HEPATITIS B IMMUNE GLOBULIN (HUMAN)) INJECTION [GRIFOLS USA, LLC]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13533-636HYPERHEP B (HEPATITIS B IMMUNE GLOBULIN (HUMAN)) INJECTION [GRIFOLS USA, LLC]26Current NDC, Legacy NDC, 8 package rows20241004_cda35690-672f-46cd-8520-e37f4d66a8d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658163hepatitis B immune globulin (human) >220 UNT in 1 ML InjectionPSNcda35690-672f-46cd-8520-e37f4d66a8d726
825160hepatitis B immune globulin (human) >220 UNT in 1 ML Prefilled SyringePSNcda35690-672f-46cd-8520-e37f4d66a8d726
825157hepatitis B immune globulin (human) >220 UNT/ML in 0.5 ML Prefilled SyringePSNcda35690-672f-46cd-8520-e37f4d66a8d726
1658174hepatitis B immune globulin (human) >220 UNT/ML in 5 ML InjectionPSNcda35690-672f-46cd-8520-e37f4d66a8d726
1658165HyperHEP B S/D >220 UNT in 1 ML InjectionPSNcda35690-672f-46cd-8520-e37f4d66a8d726
825161HyperHEP B S/D >220 UNT in 1 ML Prefilled SyringePSNcda35690-672f-46cd-8520-e37f4d66a8d726
825159HyperHEP B S/D >220 UNT/ML in 0.5 ML Prefilled SyringePSNcda35690-672f-46cd-8520-e37f4d66a8d726
1658175HyperHEP B S/D >220 UNT/ML in 5 ML InjectionPSNcda35690-672f-46cd-8520-e37f4d66a8d726
8251590.5 ML hepatitis B immune globulin 220 UNT/ML Prefilled Syringe [Hyperhep B]SBDcda35690-672f-46cd-8520-e37f4d66a8d726
16581651 ML hepatitis B immune globulin 220 UNT/ML Injection [Hyperhep B]SBDcda35690-672f-46cd-8520-e37f4d66a8d726
8251611 ML hepatitis B immune globulin 220 UNT/ML Prefilled Syringe [Hyperhep B]SBDcda35690-672f-46cd-8520-e37f4d66a8d726
16581755 ML hepatitis B immune globulin 220 UNT/ML Injection [Hyperhep B]SBDcda35690-672f-46cd-8520-e37f4d66a8d726
8251570.5 ML hepatitis B immune globulin 220 UNT/ML Prefilled SyringeSCDcda35690-672f-46cd-8520-e37f4d66a8d726
16581631 ML hepatitis B immune globulin 220 UNT/ML InjectionSCDcda35690-672f-46cd-8520-e37f4d66a8d726
8251601 ML hepatitis B immune globulin 220 UNT/ML Prefilled SyringeSCDcda35690-672f-46cd-8520-e37f4d66a8d726
16581745 ML hepatitis B immune globulin 220 UNT/ML InjectionSCDcda35690-672f-46cd-8520-e37f4d66a8d726
8251590.5 ML Hyperhep B 220 UNT/ML Prefilled SyringeSYcda35690-672f-46cd-8520-e37f4d66a8d726
8251611 ML Hyperhep B 220 UNT/ML Prefilled SyringeSYcda35690-672f-46cd-8520-e37f4d66a8d726
825157hepatitis B immune globulin 110 UNT per 0.5 ML Prefilled SyringeSYcda35690-672f-46cd-8520-e37f4d66a8d726
1658174hepatitis B immune globulin 1100 UNT per 5 ML InjectionSYcda35690-672f-46cd-8520-e37f4d66a8d726
1658163hepatitis B immune globulin 220 UNT per 1 ML InjectionSYcda35690-672f-46cd-8520-e37f4d66a8d726
825160hepatitis B immune globulin 220 UNT per 1 ML Prefilled SyringeSYcda35690-672f-46cd-8520-e37f4d66a8d726
825159Hyperhep B 110 UNT per 0.5 ML Prefilled SyringeSYcda35690-672f-46cd-8520-e37f4d66a8d726
1658175Hyperhep B 1100 UNT per 5 ML InjectionSYcda35690-672f-46cd-8520-e37f4d66a8d726
1658165Hyperhep B 220 UNT per 1 ML InjectionSYcda35690-672f-46cd-8520-e37f4d66a8d726
825161Hyperhep B 220 UNT per 1 ML Prefilled SyringeSYcda35690-672f-46cd-8520-e37f4d66a8d726

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13533-636-01135330636011 VIAL, GLASS in 1 CARTON (13533-636-01) / 1 mL in 1 VIAL, GLASS (13533-636-10) 1996-10-090000-00-00NoNoCurrent
13533-636-02135330636021 SYRINGE, GLASS in 1 CARTON (13533-636-02) / 1 mL in 1 SYRINGE, GLASS (13533-636-20) 1996-10-090000-00-00NoNoCurrent
13533-636-03135330636031 SYRINGE, GLASS in 1 CARTON (13533-636-03) / .5 mL in 1 SYRINGE, GLASS (13533-636-30) 1996-10-090000-00-00NoNoCurrent
13533-636-05135330636051 VIAL, GLASS in 1 CARTON (13533-636-05) / 5 mL in 1 VIAL, GLASS (13533-636-50) 1996-10-090000-00-00NoNoCurrent
13533-636-10135330636101 mL in 1 VIAL, GLASS1 mlHistorical
13533-636-20135330636201 mL in 1 SYRINGE, GLASS1 mlHistorical
13533-636-30135330636300.5 mL in 1 SYRINGE, GLASS0.5 mlHistorical
13533-636-50135330636505 mL in 1 VIAL, GLASS5 mlHistorical