| Product NDC: | 0052-0602 |
| Proprietary Name: | TICE BCG |
| Non Proprietary Name: | BACILLUS CALMETTE-GUERIN |
| Active Ingredient(s): | 50 mg/50mL & nbsp; BACILLUS CALMETTE-GUERIN |
| Administration Route(s): | INTRAVESICAL |
| Dosage Form(s): | POWDER, FOR SUSPENSION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0052-0602 |
| Labeler Name: | Organon Pharmaceuticals USA |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | BLA102821 |
| Marketing Category: | BLA |
| Start Marketing Date: | 20091009 |
| Package NDC: | 0052-0602-02 |
| Package Description: | 1 VIAL in 1 BOX (0052-0602-02) > 50 mL in 1 VIAL |
| NDC Code | 0052-0602-02 |
| Proprietary Name | TICE BCG |
| Package Description | 1 VIAL in 1 BOX (0052-0602-02) > 50 mL in 1 VIAL |
| Product NDC | 0052-0602 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | BACILLUS CALMETTE-GUERIN |
| Dosage Form Name | POWDER, FOR SUSPENSION |
| Route Name | INTRAVESICAL |
| Start Marketing Date | 20091009 |
| Marketing Category Name | BLA |
| Labeler Name | Organon Pharmaceuticals USA |
| Substance Name | BACILLUS CALMETTE-GUERIN |
| Strength Number | 50 |
| Strength Unit | mg/50mL |
| Pharmaceutical Classes | Live Attenuated Bacillus Calmette-Guerin Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [Chemical/Ingredient],BCG Vaccine [Chemical/Ingredient],Live Attenuated Bacillus Calmette-Guerin Immunotherapy [EPC],Increased Macrophage Proliferation [PE],Increased Immunologically Active Molecule Activity [PE] |