| 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] |