NDC 13533-318
HyperRAB
Rabies Immune Globulin (human)
HyperRAB is a Infiltration; Intramuscular Injection, Solution in the Plasma Derivative category. It is labeled and distributed by Grifols Usa, Llc. The primary component is Human Rabies Virus Immune Globulin.
| Product ID | 13533-318_0773312c-a8b5-4092-a770-ac6798abc153 |
| NDC | 13533-318 |
| Product Type | Plasma Derivative |
| Proprietary Name | HyperRAB |
| Generic Name | Rabies Immune Globulin (human) |
| Dosage Form | Injection, Solution |
| Route of Administration | INFILTRATION; INTRAMUSCULAR |
| Marketing Start Date | 1974-06-12 |
| Marketing Category | BLA / BLA |
| Application Number | BLA101144 |
| Labeler Name | GRIFOLS USA, LLC |
| Substance Name | HUMAN RABIES VIRUS IMMUNE GLOBULIN |
| Active Ingredient Strength | 300 [iU]/mL |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 13533-318-01
1 VIAL in 1 CARTON (13533-318-01) > 1 mL in 1 VIAL (13533-318-10)
| Marketing Start Date | 1974-06-12 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 13533-318-05 [13533031805]
HyperRAB INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA101144 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 1974-06-12 |
NDC 13533-318-30 [13533031830]
HyperRAB INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA101144 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2019-12-20 |
NDC 13533-318-01 [13533031801]
HyperRAB INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA101144 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 1974-06-12 |
NDC 13533-318-10 [13533031810]
HyperRAB INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA101144 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 1974-06-12 |
NDC 13533-318-03 [13533031803]
HyperRAB INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA101144 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2019-12-20 |
NDC 13533-318-50 [13533031850]
HyperRAB INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA101144 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 1974-06-12 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| HUMAN RABIES VIRUS IMMUNE GLOBULIN | 300 [iU]/mL |
NDC Crossover Matching brand name "HyperRAB" or generic name "Rabies Immune Globulin (human)"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 13533-318 | HyperRAB | Rabies Immune Globulin (Human) |
| 13533-618 | HYPERRAB | RABIES IMMUNE GLOBULIN (HUMAN) |
Trademark Results [HyperRAB]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HYPERRAB 78622898 3206857 Live/Registered |
GRIFOLS THERAPEUTICS LLC 2005-05-04 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.