NDC 58160-854

ROTARIX

Rotavirus Vaccine, Live, Oral

ROTARIX is a Kit in the Vaccine category. It is labeled and distributed by Glaxosmithkline Biologicals Sa. The primary component is .

• Product ID: 58160-854_35727529-119e-490d-8625-8f8d804443e6
• NDC: 58160-854
• Product Type: Vaccine
• Proprietary Name: ROTARIX
• Generic Name: Rotavirus Vaccine, Live, Oral
• Dosage Form: Kit
• Marketing Start Date: 2011-01-13
• Marketing Category: BLA / BLA
• Application Number: BLA125265
• Labeler Name: GlaxoSmithKline Biologicals SA
• Active Ingredient Strength: 0
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 58160-854-52

1 KIT in 1 CARTON (58160-854-52) * 10 VIAL in 1 CARTON (58160-851-10) > 1 mL in 1 VIAL (58160-851-01) * 1 mL in 1 APPLICATOR (58160-853-02)

• Marketing Start Date: 2011-01-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58160-854-52 [58160085452]

ROTARIX KIT

• Marketing Category: BLA
• Application Number: BLA125265
• Product Type: VACCINE
• Billing Unit: ML
• Marketing Start Date: 2011-01-13

Drug Details