RECOMBIVAX HB

Product NDC
50090-1716
11-digit product format
500901716
Labeler code
50090
Product ID
50090-1716_3b141f8c-3380-4cf3-b764-29b06e7f3f66
Type
VACCINE
Nonproprietary name
Hepatitis B Vaccine (Recombinant)
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
A-S Medication Solutions
Application
BLA101066
Marketing category
BLA
Marketing start
1986-07-23
Marketing end
0000-00-00
Substance
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN
Active strength
5 ug/.5mL
Pharmacologic classes
Inactivated Hepatitis B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis B Vaccines [CS],Vaccines, Inactivated [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1716-0RECOMBIVAX HB10 in 1 POUCHINJECTION, SUSPENSION1015
50090-1716-9RECOMBIVAX HB.5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION.515

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1716RECOMBIVAX HB (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [A-S MEDICATION SOLUTIONS]15Legacy NDC, 2 package rows20210617_f1ad4bca-839d-41cd-a132-a6984780912e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658154hepatitis B vaccine (recombinant) pediatric/adolescent (HepB) 5 MCG/0.5 ML InjectionPSNf1ad4bca-839d-41cd-a132-a6984780912e15
1658155RECOMBIVAX HB pediatric/adolescent vaccine 0.5 ML InjectionPSNf1ad4bca-839d-41cd-a132-a6984780912e15
16581550.5 ML hepatitis B surface antigen vaccine 0.01 MG/ML Injection [Recombivax]SBDf1ad4bca-839d-41cd-a132-a6984780912e15
16581540.5 ML hepatitis B surface antigen vaccine 0.01 MG/ML InjectionSCDf1ad4bca-839d-41cd-a132-a6984780912e15
16581550.5 ML Recombivax 0.01 MG/ML InjectionSYf1ad4bca-839d-41cd-a132-a6984780912e15
1658154hepatitis B surface antigen vaccine 5 MCG per 0.5 ML InjectionSYf1ad4bca-839d-41cd-a132-a6984780912e15
1658155Recombivax HB 5 MCG per 0.5 ML InjectionSYf1ad4bca-839d-41cd-a132-a6984780912e15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1716-05009017160010 VIAL, SINGLE-DOSE in 1 POUCH (50090-1716-0) > .5 mL in 1 VIAL, SINGLE-DOSE (50090-1716-9) 1986-07-230000-00-00NoNoCurrent
50090-1716-950090171609.5 mL in 1 VIAL, SINGLE-DOSEHistorical