NDC 0006-4897
PedvaxHIB
Haemophilus B Conjugate Vaccine (meningococcal Protein Conjugate)
PedvaxHIB is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Haemophilus Influenzae Type B Capsular Polysaccharide Meningococcal Outer Membrane Protein Conjugate Antigen.
| Product ID | 0006-4897_03e8f60a-7fe8-4dcc-933c-5ad199c03e53 |
| NDC | 0006-4897 |
| Product Type | Vaccine |
| Proprietary Name | PedvaxHIB |
| Generic Name | Haemophilus B Conjugate Vaccine (meningococcal Protein Conjugate) |
| Dosage Form | Injection, Suspension |
| Route of Administration | INTRAMUSCULAR |
| Marketing Start Date | 1989-12-20 |
| Marketing Category | BLA / BLA |
| Application Number | BLA103237 |
| Labeler Name | Merck Sharp & Dohme Corp. |
| Substance Name | HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN |
| Active Ingredient Strength | 8 ug/.5mL |
| Pharm Classes | Actively Acquired Immunity [PE],Haemophilus Vaccines [CS],Inactivated Haemophilus Influenzae B Vaccine [EPC],Vaccines, Inactivated [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 0006-4897-00
10 VIAL, SINGLE-DOSE in 1 CARTON (0006-4897-00) > .5 mL in 1 VIAL, SINGLE-DOSE (0006-4897-01)
| Marketing Start Date | 1989-12-20 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0006-4897-01 [00006489701]
PedvaxHIB INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA103237 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2013-12-13 |
NDC 0006-4897-00 [00006489700]
PedvaxHIB INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA103237 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 1989-12-20 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN | 7.5 ug/.5mL |
Pharmacological Class
- Actively Acquired Immunity [PE]
- Haemophilus Vaccines [CS]
- Inactivated Haemophilus Influenzae B Vaccine [EPC]
- Vaccines
- Inactivated [CS]
Trademark Results [PedvaxHIB]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PEDVAXHIB 73796368 1610999 Live/Registered |
MERCK & CO., INC. 1989-04-28 |
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