FDA.reportPublic FDA data

ROTARIX

Product NDC
58160-854
11-digit product format
581600854
Labeler code
58160
Product ID
58160-854_b61f04da-53e6-4b41-b3d2-12bc32a68d65
Type
VACCINE
Nonproprietary name
Rotavirus Vaccine, Live, Oral
Dosage form
KIT
Labeler
GlaxoSmithKline Biologicals SA
Application
BLA125265
Marketing category
BLA
Marketing start
2011-01-13
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct58160-854DDiscontinued by firm2026-07-31
excluded packagepackage58160-85458160-854-52DDiscontinued by firm2026-07-31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58160-854-52ML - Milliliter58160-854c4ae1ab1-df25-42e2-9830-c6e633001e8d12013-02-13

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125265RotarixRotavirus Vaccine, Live, Oral351(a)Disc2026-06-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58160-854-52581600854521 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) 1 kit2011-01-130000-00-00NoNoCurrent