| Product NDC: | 58160-854 |
| Proprietary Name: | ROTARIX |
| Non Proprietary Name: | Rotavirus Vaccine, Live, Oral |
| Active Ingredient(s): | & nbsp; Rotavirus Vaccine, Live, Oral |
| Administration Route(s): | |
| Dosage Form(s): | KIT |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 58160-854 |
| Labeler Name: | GlaxoSmithKline Biologicals SA |
| Product Type: | VACCINE |
| FDA Application Number: | BLA125265 |
| Marketing Category: | BLA |
| Start Marketing Date: | 20110113 |
| Package NDC: | 58160-854-52 |
| Package Description: | 1 KIT in 1 CARTON (58160-854-52) * 1 mL in 1 VIAL (58160-851-01) * 1 mL in 1 APPLICATOR (58160-853-02) |
| NDC Code | 58160-854-52 |
| Proprietary Name | ROTARIX |
| Package Description | 1 KIT in 1 CARTON (58160-854-52) * 1 mL in 1 VIAL (58160-851-01) * 1 mL in 1 APPLICATOR (58160-853-02) |
| Product NDC | 58160-854 |
| Product Type Name | VACCINE |
| Non Proprietary Name | Rotavirus Vaccine, Live, Oral |
| Dosage Form Name | KIT |
| Route Name | |
| Start Marketing Date | 20110113 |
| Marketing Category Name | BLA |
| Labeler Name | GlaxoSmithKline Biologicals SA |
| Substance Name | |
| Strength Number | |
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