NDC 13533-636
HYPERHEP B
Hepatitis B Immune Globulin (human)
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 |
Packaging
NDC 13533-636-01
1 VIAL, GLASS in 1 CARTON (13533-636-01) > 1 mL in 1 VIAL, GLASS (13533-636-10)
| Marketing Start Date | 1996-10-09 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 13533-636-05 [13533063605]
HYPERHEP B S/D INJECTION
| Marketing Category | BLA |
| Application Number | BLA101146 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 1996-10-09 |
NDC 13533-636-50 [13533063650]
HYPERHEP B S/D INJECTION
| Marketing Category | BLA |
| Application Number | BLA101146 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2012-11-29 |
NDC 13533-636-20 [13533063620]
HYPERHEP B S/D INJECTION
| Marketing Category | BLA |
| Application Number | BLA101146 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2012-11-29 |
NDC 13533-636-03 [13533063603]
HYPERHEP B S/D INJECTION
| Marketing Category | BLA |
| Application Number | BLA101146 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 1996-10-09 |
NDC 13533-636-30 [13533063630]
HYPERHEP B S/D INJECTION
| Marketing Category | BLA |
| Application Number | BLA101146 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2012-11-29 |
NDC 13533-636-02 [13533063602]
HYPERHEP B S/D INJECTION
| Marketing Category | BLA |
| Application Number | BLA101146 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 1996-10-09 |
NDC 13533-636-01 [13533063601]
HYPERHEP B S/D INJECTION
| Marketing Category | BLA |
| Application Number | BLA101146 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 1996-10-09 |
NDC 13533-636-10 [13533063610]
HYPERHEP B S/D INJECTION
| Marketing Category | BLA |
| Application Number | BLA101146 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2012-11-29 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN | 220 [iU]/mL |
Pharmacological Class
- Human Immunoglobulin [EPC]
- Passively Acquired Immunity [PE]
- Virus Neutralization [MoA]
- Virus-specific Hyperimmune Globulins [EXT]
- Immunoglobulins [CS]
NDC Crossover Matching brand name "HYPERHEP B" or generic name "Hepatitis B Immune Globulin (human)"
| 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) |
Trademark Results [HYPERHEP B]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HYPERHEP B 78622916 3197566 Live/Registered |
GRIFOLS THERAPEUTICS LLC 2005-05-04 |
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