NDC 49281-215

TENIVAC

Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated) And Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated)

TENIVAC is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Sanofi Pasteur Inc.. The primary component is Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated); Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated).

• Product ID: 49281-215_27f99b25-f744-4640-9f8c-06a4c92bd9e4
• NDC: 49281-215
• Product Type: Vaccine
• Proprietary Name: TENIVAC
• Generic Name: Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated) And Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated)
• Dosage Form: Injection, Suspension
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2010-12-08
• Marketing Category: BLA / BLA
• Application Number: BLA103171
• Labeler Name: Sanofi Pasteur Inc.
• Substance Name: CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)
• Active Ingredient Strength: 5 [Lf]/.5mL; [Lf]/.5mL
• Pharm Classes: Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2024-12-31

Packaging

NDC 49281-215-10

10 VIAL, SINGLE-DOSE in 1 PACKAGE (49281-215-10) > .5 mL in 1 VIAL, SINGLE-DOSE (49281-215-58)

• Marketing Start Date: 2010-12-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49281-215-10 [49281021510]

TENIVAC INJECTION, SUSPENSION

• Marketing Category: BLA
• Application Number: BLA103171
• Product Type: VACCINE
• Billing Unit: ML
• Marketing Start Date: 2010-12-08

NDC 49281-215-88 [49281021588]

TENIVAC INJECTION, SUSPENSION

• Marketing Category: BLA
• Application Number: BLA103171
• Product Type: VACCINE
• Billing Unit: ML
• Marketing Start Date: 2016-02-26

NDC 49281-215-15 [49281021515]

TENIVAC INJECTION, SUSPENSION

• Marketing Category: BLA
• Application Number: BLA103171
• Product Type: VACCINE
• Billing Unit: ML
• Marketing Start Date: 2010-12-08

NDC 49281-215-58 [49281021558]

TENIVAC INJECTION, SUSPENSION

• Marketing Category: BLA
• Application Number: BLA103171
• Product Type: VACCINE
• Billing Unit: ML
• Marketing Start Date: 2016-02-26

Drug Details

Active Ingredients

Ingredient	Strength
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)	5 [Lf]/.5mL

Pharmacological Class

• 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]