RotaTeq is a Oral Solution in the Vaccine category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Human Rotavirus A Type G1p7(5) Strain Wi79 Live Antigen; Human Rotavirus A Type G2p7(5) Strain Sc2 Live Antigen; Human Rotavirus A Type G3p7(5) Strain Wi78 Live Antigen; Human Rotavirus A Type G4p7(5) Strain Brb Live Antigen; Human Rotavirus A Type G6p1a(8) Strain Wi79 Live Antigen.
Product ID | 0006-4047_05a6cc83-852a-4492-b7f0-83579fecf1a2 |
NDC | 0006-4047 |
Product Type | Vaccine |
Proprietary Name | RotaTeq |
Generic Name | Rotavirus Vaccine, Live, Oral, Pentavalent |
Dosage Form | Solution |
Route of Administration | ORAL |
Marketing Start Date | 2006-02-03 |
Marketing Category | BLA / BLA |
Application Number | BLA125122 |
Labeler Name | Merck Sharp & Dohme Corp. |
Substance Name | HUMAN ROTAVIRUS A TYPE G1P7(5) STRAIN WI79 LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G2P7(5) STRAIN SC2 LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G3P7(5) STRAIN WI78 LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G4P7(5) STRAIN BRB LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G6P1A(8) STRAIN WI79 LIVE ANTIGEN |
Active Ingredient Strength | 2200000 [iU]/2mL; [iU]/2mL; [iU]/2mL; [iU]/2mL; [iU]/2mL |
Pharm Classes | Live Rotavirus Vaccine [EPC],Actively Acquired Immunity [PE],Rotavirus Vaccines [CS],Vaccines, Live, Unattenuated [CS],Live Rotavirus Vaccine [EPC],Actively Acquired Immunity [PE],Rotavirus Vaccines [CS],Vaccines, Live, Unattenuated [CS],Live Rotavirus Vaccine [EPC],Actively Acquired Immunity [PE],Rotavirus Vaccines [CS],Vaccines, Live, Unattenuated [CS],Live Rotavirus Vaccine [EPC],Actively Acquired Immunity [PE],Rotavirus Vaccines [CS],Vaccines, Live, Unattenuated [CS],Live Rotavirus Vaccine [EPC],Actively Acquired Immunity [PE],Rotavirus Vaccines [CS],Vaccines, Live, Unattenuated [CS] |
NDC Exclude Flag | N |
Listing Certified Through | 2020-12-31 |
Marketing Start Date | 2006-02-03 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | BLA |
Application Number | BLA125122 |
Product Type | VACCINE |
Billing Unit | ML |
Marketing Start Date | 2010-12-13 |
Marketing Category | BLA |
Application Number | BLA125122 |
Product Type | VACCINE |
Billing Unit | ML |
Marketing Start Date | 2006-02-03 |
Marketing Category | BLA |
Application Number | BLA125122 |
Product Type | VACCINE |
Billing Unit | ML |
Marketing Start Date | 2006-02-03 |
Ingredient | Strength |
---|---|
HUMAN ROTAVIRUS A TYPE G1P7(5) STRAIN WI79 LIVE ANTIGEN | 2200000 [iU]/2mL |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ROTATEQ 76494554 not registered Dead/Abandoned |
Merck & Co., Inc. 2003-03-04 |
ROTATEQ 75666657 2742325 Live/Registered |
MERCK SHARP & DOHME CORP. 1999-03-24 |