FDA.reportPublic FDA data

INFANRIX

Product NDC
50090-2883
11-digit product format
500902883
Labeler code
50090
Product ID
50090-2883_4b64831f-ea62-443d-acb9-7096f143b998
Type
VACCINE
Nonproprietary name
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
Dosage form
SUSPENSION
Route
INTRAMUSCULAR
Labeler
A-S Medication Solutions
Application
BLA103647
Marketing category
BLA
Marketing start
2009-07-24
Marketing end
0000-00-00
Substance
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED)
Active strength
10 [iU]/.5mL; [iU]/.5mL; ug/.5mL; ug/.5mL; ug/.5mL
Pharmacologic classes
Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Tetanus Toxoid [CS],Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Diphtheria Toxoid [CS],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Pertussis Vaccine [CS],Vaccines, Inactivated [CS],Pertussis Vaccine [CS],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Pertussis Vaccine [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
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 productproduct50090-2883IInactivated by FDA2026-08-03
excluded packagepackage50090-288350090-2883-0IInactivated by FDA2026-08-03

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2883-02023-01-30C16284748780-1f386c649-b4a8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use INFANRIX safely and effectively. See full prescribing information for INFANRIX. INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) Suspension for Intramuscular Injection Initial U.S. Approval: 1997

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103647InfanrixDiphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed351(a)Rx2026-06-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2883-05009028830010 SYRINGE in 1 CARTON (50090-2883-0) > .5 mL in 1 SYRINGE (50090-2883-9) 10 syringe2009-07-240000-00-00NoNoCurrent