Product NDC: | 0006-4047 |
Proprietary Name: | RotaTeq |
Non Proprietary Name: | Rotavirus Vaccine, Live, Oral, Pentavalent |
Active Ingredient(s): | 2200000; 2800000; 2200000; 2000000; 2300000 [iU]/2mL; [iU]/2mL; [iU]/2mL; [iU]/2mL; [iU]/2mL & nbsp; Rotavirus Vaccine, Live, Oral, Pentavalent |
Administration Route(s): | ORAL |
Dosage Form(s): | SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0006-4047 |
Labeler Name: | Merck Sharp & Dohme Corp. |
Product Type: | VACCINE |
FDA Application Number: | BLA125122 |
Marketing Category: | BLA |
Start Marketing Date: | 20060203 |
Package NDC: | 0006-4047-41 |
Package Description: | 10 POUCH in 1 CARTON (0006-4047-41) > 1 TUBE in 1 POUCH (0006-4047-01) > 2 mL in 1 TUBE |
NDC Code | 0006-4047-41 |
Proprietary Name | RotaTeq |
Package Description | 10 POUCH in 1 CARTON (0006-4047-41) > 1 TUBE in 1 POUCH (0006-4047-01) > 2 mL in 1 TUBE |
Product NDC | 0006-4047 |
Product Type Name | VACCINE |
Non Proprietary Name | Rotavirus Vaccine, Live, Oral, Pentavalent |
Dosage Form Name | SOLUTION |
Route Name | ORAL |
Start Marketing Date | 20060203 |
Marketing Category Name | BLA |
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 |
Strength Number | 2200000; 2800000; 2200000; 2000000; 2300000 |
Strength Unit | [iU]/2mL; [iU]/2mL; [iU]/2mL; [iU]/2mL; [iU]/2mL |
Pharmaceutical Classes | Live Rotavirus Vaccine [EPC],Actively Acquired Immunity [PE],Rotavirus Vaccines [Chemical/Ingredient],Vaccines, Live, Unattenuated [Chemical/Ingredient],Live Rotavirus Vaccine [EPC],Actively Acquired Immunity [PE],Rotavirus Vaccines [Chemical/Ingredient],Vaccines, Live, Unattenuated [Chemical/Ingredient],Live Rotavirus Vaccine [EPC],Actively Acquired Immunity [PE],Rotavirus Vaccines [Chemical/Ingredient],Vaccines, Live, Unattenuated [Chemical/Ingredient],Live Rotavirus Vaccine [EPC],Actively Acquired Immunity [PE],Rotavirus Vaccines [Chemical/Ingredient],Vaccines, Live, Unattenuated [Chemical/Ingredient],Live Rotavirus Vaccine [EPC],Actively Acquired Immunity [PE],Rotavirus Vaccines [Chemical/Ingredient],Vaccines, Live, Unattenuated [Chemical/Ingredient] |