FDA.reportPublic FDA data

BOOSTRIX

Product NDC
58160-842
11-digit product format
581600842
Labeler code
58160
Product ID
58160-842_5045e31e-3eda-47ac-b374-0ab16dad194e
Type
VACCINE
Nonproprietary name
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed
Dosage form
SUSPENSION
Route
INTRAMUSCULAR
Labeler
GlaxoSmithKline Biologicals SA
Application
BLA125106
Marketing category
BLA
Marketing start
2009-07-24
Substance
BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)
Active strength
8; 2.5; 8; 5; 2.5 ug/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL
Pharmacologic classes
Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BOOSTRIX
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)8 ug/.5mL
BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED)2.5 ug/.5mL
BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED)8 ug/.5mL
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)5 [iU]/.5mL
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)2.5 [iU]/.5mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58160-842-01BOOSTRIX0.5 mL in 1 VIALSUSPENSION0.544
58160-842-11BOOSTRIX10 in 1 CARTONSUSPENSION1044
58160-842-43BOOSTRIX0.5 mL in 1 SYRINGESUSPENSION0.544
58160-842-52BOOSTRIX10 in 1 CARTONSUSPENSION1044

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58160-842-01ML - Milliliter58160-842f5d9273f-dc84-4ced-95f3-544ca338140412013-03-03
58160-842-05ML - Milliliter58160-84242abe1c5-7544-48a2-af12-f7e5a5dbe5bd12019-03-12
58160-842-11ML - Milliliter58160-8429bd4e818-dd6d-492a-83e6-2aebd7a6a3fe12013-02-13
58160-842-32ML - Milliliter58160-842ddb79a9a-2048-4d2f-b126-ab56fcd3916c12013-02-11
58160-842-34ML - Milliliter58160-842997a3751-9a0f-4472-aeb8-3c7f668cb46312018-01-12
58160-842-43ML - Milliliter58160-842d43a9d1e-ee8b-4d01-b6da-bf13b7df7eea12013-03-03
58160-842-52ML - Milliliter58160-84247b70527-7771-4b40-8142-77dd16c585e812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENT8C367IY4EYBOOSTRIX (TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS VACCINE, ADSORBED) SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]22
BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENTI05O535NV6BOOSTRIX (TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS VACCINE, ADSORBED) SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]22
BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED)ACTIVE INGREDIENTQSN5XO8ZSUBOOSTRIX (TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS VACCINE, ADSORBED) SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]22
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENTK3W1N8YP13BOOSTRIX (TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS VACCINE, ADSORBED) SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]22
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENTIRH51QN26HBOOSTRIX (TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS VACCINE, ADSORBED) SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]22
BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETY8C367IY4EYBOOSTRIX (TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS VACCINE, ADSORBED) SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]22
BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETYI05O535NV6BOOSTRIX (TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS VACCINE, ADSORBED) SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]22
BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED)ACTIVE MOIETYQSN5XO8ZSUBOOSTRIX (TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS VACCINE, ADSORBED) SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]22
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETYK3W1N8YP13BOOSTRIX (TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS VACCINE, ADSORBED) SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]22
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETYIRH51QN26HBOOSTRIX (TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS VACCINE, ADSORBED) SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]22
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0BOOSTRIX (TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS VACCINE, ADSORBED) SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]22
FORMALDEHYDEINACTIVE INGREDIENT1HG84L3525BOOSTRIX (TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS VACCINE, ADSORBED) SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]22
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBOOSTRIX (TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS VACCINE, ADSORBED) SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]22
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XBOOSTRIX (TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS VACCINE, ADSORBED) SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58160-842BOOSTRIX (TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS VACCINE, ADSORBED) SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]42Current NDC, Legacy NDC, 4 package rows20241208_cd98bff9-4602-4268-d68d-029a14a5513b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1300378BOOSTRIX vaccine 0.5 ML InjectionPSNcd98bff9-4602-4268-d68d-029a14a5513b44
1300370BOOSTRIX vaccine 0.5 ML Prefilled SyringePSNcd98bff9-4602-4268-d68d-029a14a5513b44
1300368Tdap (generic for Boostrix) 0.5 ML Prefilled SyringePSNcd98bff9-4602-4268-d68d-029a14a5513b44
1300377tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Tdap generic for Boostrix) 0.5 ML InjectionPSNcd98bff9-4602-4268-d68d-029a14a5513b44
13003700.5 ML Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 0.016 MG/ML / Bordetella pertussis pertactin vaccine, inactivated 0.005 MG/ML / Bordetella pertussis toxoid vaccine, inactivated 0.016 MG/ML / diphtheria toxoid vaccine, inactivated 5 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML Prefilled Syringe [Boostrix]SBDcd98bff9-4602-4268-d68d-029a14a5513b44
13003780.5 ML Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 0.016 MG/ML / Bordetella pertussis pertactin vaccine, inactivated 0.005 UNT/ML / Bordetella pertussis toxoid vaccine, inactivated 0.016 MG/ML / diphtheria toxoid vaccine, inactivated 5 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML Injection [Boostrix]SBDcd98bff9-4602-4268-d68d-029a14a5513b44
13003680.5 ML Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 0.016 MG/ML / Bordetella pertussis pertactin vaccine, inactivated 0.005 MG/ML / Bordetella pertussis toxoid vaccine, inactivated 0.016 MG/ML / diphtheria toxoid vaccine, inactivated 5 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML Prefilled SyringeSCDcd98bff9-4602-4268-d68d-029a14a5513b44
13003770.5 ML Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 0.016 MG/ML / Bordetella pertussis pertactin vaccine, inactivated 0.005 UNT/ML / Bordetella pertussis toxoid vaccine, inactivated 0.016 MG/ML / diphtheria toxoid vaccine, inactivated 5 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML InjectionSCDcd98bff9-4602-4268-d68d-029a14a5513b44
1300378Boostrix (Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 8 MCG / Bordetella pertussis pertactin vaccine, inactivated 2.5 MCG / Bordetella pertussis toxoid vaccine, inactivated 8 MCG / diphtheria toxoid vaccine, inactivated 2.5 UNT / tetanus toxoid vaccine, inactivated 5 UNT) per 0.5 ML InjectionSYcd98bff9-4602-4268-d68d-029a14a5513b44
1300370Boostrix (Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 8 MCG / Bordetella pertussis pertactin vaccine, inactivated 2.5 MCG / Bordetella pertussis toxoid vaccine, inactivated 8 MCG / diphtheria toxoid vaccine, inactivated 2.5 UNT / tetanus toxoid vaccine, inactivated 5 UNT) per 0.5 ML Prefilled SyringeSYcd98bff9-4602-4268-d68d-029a14a5513b44
1300370Boostrix Tdap (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) 0.5 ML Prefilled SyringeSYcd98bff9-4602-4268-d68d-029a14a5513b44
1300378Boostrix Tdap (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) InjectionSYcd98bff9-4602-4268-d68d-029a14a5513b44
1300377Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 8 MCG / Bordetella pertussis pertactin vaccine, inactivated 2.5 MCG / Bordetella pertussis toxoid vaccine, inactivated 8 MCG / diphtheria toxoid vaccine, inactivated 2.5 UNT / tetanus toxoid vaccine 5 UNT per 0.5 ML InjectionSYcd98bff9-4602-4268-d68d-029a14a5513b44
1300368Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 8 MCG / Bordetella pertussis pertactin vaccine, inactivated 2.5 MCG / Bordetella pertussis toxoid vaccine, inactivated 8 MCG / diphtheria toxoid vaccine, inactivated 2.5 UNT / tetanus toxoid vaccine, inactivated 5 UNT per 0.5 ML Prefilled SyringeSYcd98bff9-4602-4268-d68d-029a14a5513b44
1300377Tdap (tetanus toxoid vaccine, inactivated 5 UNT / diphtheria toxoid vaccine, inactivated 2.5 UNT / acellular pertussis vaccine, inactivated 18.5 MCG) per 0.5 ML InjectionSYcd98bff9-4602-4268-d68d-029a14a5513b44
1300368Tdap (tetanus toxoid vaccine, inactivated 5 UNT / diphtheria toxoid vaccine, inactivated 2.5 UNT / acellular pertussis vaccine, inactivated 18.5 MCG) per 0.5 ML Prefilled SyringeSYcd98bff9-4602-4268-d68d-029a14a5513b44
1300368tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Tdap generic for Boostrix) 0.5 ML Prefilled SyringeSYcd98bff9-4602-4268-d68d-029a14a5513b44
1300370BOOSTRIX vaccine 0.5 ML Prefilled SyringePSNc3c03458-942c-4565-8a9c-1901bb0d2db026
1300368Tdap (generic for Boostrix) 0.5 ML Prefilled SyringePSNc3c03458-942c-4565-8a9c-1901bb0d2db026
13003700.5 ML Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 0.016 MG/ML / Bordetella pertussis pertactin vaccine, inactivated 0.005 MG/ML / Bordetella pertussis toxoid vaccine, inactivated 0.016 MG/ML / diphtheria toxoid vaccine, inactivated 5 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML Prefilled Syringe [Boostrix]SBDc3c03458-942c-4565-8a9c-1901bb0d2db026
13003680.5 ML Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 0.016 MG/ML / Bordetella pertussis pertactin vaccine, inactivated 0.005 MG/ML / Bordetella pertussis toxoid vaccine, inactivated 0.016 MG/ML / diphtheria toxoid vaccine, inactivated 5 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML Prefilled SyringeSCDc3c03458-942c-4565-8a9c-1901bb0d2db026
1300370Boostrix (Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 8 MCG / Bordetella pertussis pertactin vaccine, inactivated 2.5 MCG / Bordetella pertussis toxoid vaccine, inactivated 8 MCG / diphtheria toxoid vaccine, inactivated 2.5 UNT / tetanus toxoid vaccine, inactivated 5 UNT) per 0.5 ML Prefilled SyringeSYc3c03458-942c-4565-8a9c-1901bb0d2db026
1300370Boostrix Tdap (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) 0.5 ML Prefilled SyringeSYc3c03458-942c-4565-8a9c-1901bb0d2db026
1300368Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 8 MCG / Bordetella pertussis pertactin vaccine, inactivated 2.5 MCG / Bordetella pertussis toxoid vaccine, inactivated 8 MCG / diphtheria toxoid vaccine, inactivated 2.5 UNT / tetanus toxoid vaccine, inactivated 5 UNT per 0.5 ML Prefilled SyringeSYc3c03458-942c-4565-8a9c-1901bb0d2db026
1300368Tdap (tetanus toxoid vaccine, inactivated 5 UNT / diphtheria toxoid vaccine, inactivated 2.5 UNT / acellular pertussis vaccine, inactivated 18.5 MCG) per 0.5 ML Prefilled SyringeSYc3c03458-942c-4565-8a9c-1901bb0d2db026
1300368tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Tdap generic for Boostrix) 0.5 ML Prefilled SyringeSYc3c03458-942c-4565-8a9c-1901bb0d2db026
1300378BOOSTRIX vaccine 0.5 ML InjectionPSN46993726-584e-4907-ac4d-94e59b236b8219
1300377tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Tdap generic for Boostrix) 0.5 ML InjectionPSN46993726-584e-4907-ac4d-94e59b236b8219
13003780.5 ML Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 0.016 MG/ML / Bordetella pertussis pertactin vaccine, inactivated 0.005 UNT/ML / Bordetella pertussis toxoid vaccine, inactivated 0.016 MG/ML / diphtheria toxoid vaccine, inactivated 5 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML Injection [Boostrix]SBD46993726-584e-4907-ac4d-94e59b236b8219
13003770.5 ML Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 0.016 MG/ML / Bordetella pertussis pertactin vaccine, inactivated 0.005 UNT/ML / Bordetella pertussis toxoid vaccine, inactivated 0.016 MG/ML / diphtheria toxoid vaccine, inactivated 5 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML InjectionSCD46993726-584e-4907-ac4d-94e59b236b8219
1300378Boostrix (Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 8 MCG / Bordetella pertussis pertactin vaccine, inactivated 2.5 MCG / Bordetella pertussis toxoid vaccine, inactivated 8 MCG / diphtheria toxoid vaccine, inactivated 2.5 UNT / tetanus toxoid vaccine, inactivated 5 UNT) per 0.5 ML InjectionSY46993726-584e-4907-ac4d-94e59b236b8219
1300378Boostrix Tdap (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) InjectionSY46993726-584e-4907-ac4d-94e59b236b8219
1300377Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 8 MCG / Bordetella pertussis pertactin vaccine, inactivated 2.5 MCG / Bordetella pertussis toxoid vaccine, inactivated 8 MCG / diphtheria toxoid vaccine, inactivated 2.5 UNT / tetanus toxoid vaccine 5 UNT per 0.5 ML InjectionSY46993726-584e-4907-ac4d-94e59b236b8219
1300377Tdap (tetanus toxoid vaccine, inactivated 5 UNT / diphtheria toxoid vaccine, inactivated 2.5 UNT / acellular pertussis vaccine, inactivated 18.5 MCG) per 0.5 ML InjectionSY46993726-584e-4907-ac4d-94e59b236b8219

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58160-842-01581600842010.5 mL in 1 VIAL0.5 mlHistorical
58160-842-115816008421110 VIAL in 1 CARTON (58160-842-11) / .5 mL in 1 VIAL (58160-842-01) 10 vial2009-07-240000-00-00NoNoCurrent
58160-842-43581600842430.5 mL in 1 SYRINGE0.5 mlHistorical
58160-842-525816008425210 SYRINGE in 1 CARTON (58160-842-52) / .5 mL in 1 SYRINGE (58160-842-43) 10 syringe2009-07-240000-00-00NoNoCurrent