Home NDC 58160-818 Hiberix
Product NDC 58160-818
11-digit product format 581600818
Labeler code 58160
Product ID 58160-818_6321e15a-da1f-42a3-b3ac-82611b5c9d7f
Type VACCINE
Nonproprietary name Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)
Dosage form KIT
Labeler GlaxoSmithKline Biologicals SA
Application BLA125347
Marketing category BLA
Marketing start 2015-12-21
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 58160-818-11 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 58160-818-11 0efc9e666f02…f202fb6c5f17…
Additional Listing Data#
Finished product Yes
Brand name base Hiberix
Listing expiration 2026-12-31 DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58160-816-01 Hiberix 0.5 mL in 1 VIAL INJECTION, POWDER, FOR SOLUTION 5 mL 10 ug in 0.5mL 22 58160-816-05 Hiberix 10 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 10 ug in 0.5mL 22 58160-817-01 Hiberix 0.85 mL in 1 VIAL SOLUTION 8.5 mL 1 mL in 1mL 22 58160-817-05 Hiberix 10 in 1 PACKAGE SOLUTION 1 mL in 1mL 22 58160-818-11 Hiberix 1 in 1 CARTON KIT 1 22
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HAEMOPHILUS INFLUENZAE TYPE B STRAIN 20752 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN ACTIVE INGREDIENT C9R35M8XV6 HIBERIX (HAEMOPHILUS B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE)) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAXOSMITHKLINE BIOLOGICALS SA] 8 HAEMOPHILUS INFLUENZAE TYPE B STRAIN 20752 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN ACTIVE MOIETY C9R35M8XV6 HIBERIX (HAEMOPHILUS B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE)) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAXOSMITHKLINE BIOLOGICALS SA] 8 LACTOSE INACTIVE INGREDIENT J2B2A4N98G HIBERIX (HAEMOPHILUS B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE)) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAXOSMITHKLINE BIOLOGICALS SA] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58160-818 HIBERIX (HAEMOPHILUS B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE)) KIT [GLAXOSMITHKLINE BIOLOGICALS SA] 21 Current NDC, Legacy NDC, 5 package rows 20250212_745ff8df-1618-4b76-9aa1-6f42752c0dda.zip
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125347 Hiberix Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) 351(a) Rx 2026-06-01
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1300808 Haemophilus b conjugate vaccine (tetanus toxoid conjugate) (Hib generic for Hiberix) 0.5 mL Injection PSN 745ff8df-1618-4b76-9aa1-6f42752c0dda 22 1300810 HIBERIX vaccine 0.5 ML Injection PSN 745ff8df-1618-4b76-9aa1-6f42752c0dda 22 1300810 0.5 ML Haemophilus influenzae type b strain 20752, capsular polysaccharide inactivated tetanus toxoid conjugate vaccine 0.07 MG/ML Injection [Hiberix] SBD 745ff8df-1618-4b76-9aa1-6f42752c0dda 22 1300808 0.5 ML Haemophilus influenzae type b strain 20752, capsular polysaccharide inactivated tetanus toxoid conjugate vaccine 0.07 MG/ML Injection SCD 745ff8df-1618-4b76-9aa1-6f42752c0dda 22 1300810 0.5 ML Hiberix 0.07 MG/ML Injection SY 745ff8df-1618-4b76-9aa1-6f42752c0dda 22 1300808 Haemophilus influenzae type b strain 20,752, capsular polysaccharide inactivated tetanus toxoid conjugate vaccine 35 MCG per 0.5 ML Injection SY 745ff8df-1618-4b76-9aa1-6f42752c0dda 22 1300810 Hiberix (Haemophilus influenzae type b strain 20,752, capsular polysaccharide (10 MCG) inactivated tetanus toxoid (25 MCG) conjugate vaccine) per 0.5 ML Injection SY 745ff8df-1618-4b76-9aa1-6f42752c0dda 22 1300810 Hiberix (Haemophilus influenzae type b strain 20,752, capsular polysaccharide inactivated tetanus toxoid conjugate vaccine) 35 MCG per 0.5 ML Injection SY 745ff8df-1618-4b76-9aa1-6f42752c0dda 22
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58160-816-01 58160081601 0.5 mL in 1 VIAL 0.5 ml Historical 58160-816-05 58160081605 10 in 1 CARTON Historical 58160-817-01 58160081701 0.85 mL in 1 VIAL 0.85 ml Historical 58160-817-05 58160081705 10 in 1 PACKAGE Historical 58160-818-11 58160081811 1 KIT in 1 CARTON (58160-818-11) * 10 VIAL in 1 CARTON (58160-816-05) / .5 mL in 1 VIAL (58160-816-01) * 10 VIAL in 1 PACKAGE (58160-817-05) / .85 mL in 1 VIAL (58160-817-01) 1 kit 2015-12-21 0000-00-00 No No Current