RECOMBIVAX HB

Product NDC
50090-1719
11-digit product format
500901719
Labeler code
50090
Product ID
50090-1719_8136b6d3-5be4-462d-8fc6-b81acae9f91c
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
10 ug/mL
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
50090-1719-0RECOMBIVAX HB10 in 1 POUCHINJECTION, SUSPENSION1016
50090-1719-9RECOMBIVAX HB1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION116

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1719RECOMBIVAX HB (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [A-S MEDICATION SOLUTIONS]16Legacy NDC, 2 package rows20210617_e80cfadc-71b6-4881-b5f7-2be67adbf8b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658149hepatitis B vaccine (recombinant) adult (HepB) 10 MCG in 1 ML InjectionPSNe80cfadc-71b6-4881-b5f7-2be67adbf8b816
1658150RECOMBIVAX HB adult vaccine 1 ML InjectionPSNe80cfadc-71b6-4881-b5f7-2be67adbf8b816
16581501 ML hepatitis B surface antigen vaccine 0.01 MG/ML Injection [Recombivax]SBDe80cfadc-71b6-4881-b5f7-2be67adbf8b816
16581491 ML hepatitis B surface antigen vaccine 0.01 MG/ML InjectionSCDe80cfadc-71b6-4881-b5f7-2be67adbf8b816
16581501 ML Recombivax 0.01 MG/ML InjectionSYe80cfadc-71b6-4881-b5f7-2be67adbf8b816
1658149hepatitis B surface antigen vaccine 10 MCG per 1 ML InjectionSYe80cfadc-71b6-4881-b5f7-2be67adbf8b816
1658150Recombivax HB 10 MCG per 1 ML InjectionSYe80cfadc-71b6-4881-b5f7-2be67adbf8b816

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1719-05009017190010 VIAL, SINGLE-DOSE in 1 POUCH (50090-1719-0) > 1 mL in 1 VIAL, SINGLE-DOSE (50090-1719-9) 1986-07-230000-00-00NoNoCurrent
50090-1719-9500901719091 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical