HYPERHEP B is a Intramuscular Injection in the Plasma Derivative category. It is labeled and distributed by Grifols Usa, Llc. The primary component is Human Hepatitis B Virus Immune Globulin.
Product ID | 13533-636_391b2218-8a15-4e5e-8717-aa49efcc2210 |
NDC | 13533-636 |
Product Type | Plasma Derivative |
Proprietary Name | HYPERHEP B |
Generic Name | Hepatitis B Immune Globulin (human) |
Dosage Form | Injection |
Route of Administration | INTRAMUSCULAR |
Marketing Start Date | 1996-10-09 |
Marketing Category | BLA / BLA |
Application Number | BLA101146 |
Labeler Name | GRIFOLS USA, LLC |
Substance Name | HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN |
Active Ingredient Strength | 220 [iU]/mL |
Pharm Classes | Human Immunoglobulin [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE], Virus Neutralization [MoA], Virus-specific Hyperimmune Globulins [EXT] |
NDC Exclude Flag | N |
Listing Certified Through | 2023-12-31 |
Marketing Start Date | 1996-10-09 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | BLA |
Application Number | BLA101146 |
Product Type | PLASMA DERIVATIVE |
Billing Unit | ML |
Marketing Start Date | 1996-10-09 |
Marketing Category | BLA |
Application Number | BLA101146 |
Product Type | PLASMA DERIVATIVE |
Billing Unit | ML |
Marketing Start Date | 2012-11-29 |
Marketing Category | BLA |
Application Number | BLA101146 |
Product Type | PLASMA DERIVATIVE |
Billing Unit | ML |
Marketing Start Date | 2012-11-29 |
Marketing Category | BLA |
Application Number | BLA101146 |
Product Type | PLASMA DERIVATIVE |
Billing Unit | ML |
Marketing Start Date | 1996-10-09 |
Marketing Category | BLA |
Application Number | BLA101146 |
Product Type | PLASMA DERIVATIVE |
Billing Unit | ML |
Marketing Start Date | 2012-11-29 |
Marketing Category | BLA |
Application Number | BLA101146 |
Product Type | PLASMA DERIVATIVE |
Billing Unit | ML |
Marketing Start Date | 1996-10-09 |
Marketing Category | BLA |
Application Number | BLA101146 |
Product Type | PLASMA DERIVATIVE |
Billing Unit | ML |
Marketing Start Date | 1996-10-09 |
Marketing Category | BLA |
Application Number | BLA101146 |
Product Type | PLASMA DERIVATIVE |
Billing Unit | ML |
Marketing Start Date | 2012-11-29 |
Ingredient | Strength |
---|---|
HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN | 220 [iU]/mL |
NDC | Brand Name | Generic Name |
---|---|---|
13533-636 | HYPERHEP B | HEPATITIS B IMMUNE GLOBULIN (HUMAN) |
53270-0051 | HepaGam B | Hepatitis B Immune Globulin (Human) |
53270-0052 | HepaGam B | Hepatitis B Immune Globulin (Human) |
70504-0051 | HepaGam B | Hepatitis B Immune Globulin (Human) |
70504-0052 | HepaGam B | Hepatitis B Immune Globulin (Human) |
70504-0053 | HepaGam B | Hepatitis B Immune Globulin (Human) |
70504-0054 | HepaGam B | Hepatitis B Immune Globulin (Human) |
69800-4202 | Nabi-HB | Hepatitis B Immune Globulin (Human) |
69800-4203 | Nabi-HB | Hepatitis B Immune Globulin (Human) |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HYPERHEP B 78622916 3197566 Live/Registered |
GRIFOLS THERAPEUTICS LLC 2005-05-04 |