"58160-740-21" National Drug Code (NDC)

Rotarix 10 APPLICATOR in 1 CARTON (58160-740-21) / 1.5 mL in 1 APPLICATOR (58160-740-02)
(GlaxoSmithKline Biologicals SA)

NDC Code58160-740-21
Package Description10 APPLICATOR in 1 CARTON (58160-740-21) / 1.5 mL in 1 APPLICATOR (58160-740-02)
Product NDC58160-740
Product Type NameVACCINE
Proprietary NameRotarix
Non-Proprietary NameRotavirus Vaccine, Live, Oral
Dosage FormSOLUTION
UsageORAL
Start Marketing Date20230201
Marketing Category NameBLA
Application NumberBLA125265
ManufacturerGlaxoSmithKline Biologicals SA
Substance NameHUMAN ROTAVIRUS A TYPE G1P(8) STRAIN RIX4414 LIVE ANTIGEN
Strength1000
Strength Unit[CCID_50]/mL
Pharmacy ClassesActively Acquired Immunity [PE], Live Attenuated Rotavirus Vaccine [EPC], Rotavirus Vaccines [CS], Vaccines, Attenuated [CS]

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