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United States · US · US:49281-215_737f89ae-a592-44db-94a4-8a4524ee027f

TENIVAC

UNIISPL

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerSanofi Vaccines US Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4928121510
    10 VIAL, SINGLE-DOSE in 1 PACKAGE (49281-215-10) / .5 mL in 1 VIAL, SINGLE-DOSE (49281-215-58)
  • ndc11
    4928121515
    10 SYRINGE in 1 PACKAGE (49281-215-15) / .5 mL in 1 SYRINGE (49281-215-88)

Annotations

UNII (FDA Substance ID)
K3W1N8YP13
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "K3W1N8YP13",
    "rxcui": null,
    "inchikey": null,
    "display_name": "CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "spl_meta": {
    "1a87f53c-0c8a-4c66-9048-2a0cf60a6a5c": {
      "match": "brand_token",
      "title": "TENIVAC (CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) AND CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)) INJECTION, SUSPENSION [SANOFI VACCINES US INC.]",
      "spl_version": "14",
      "published_date": "2026-04-30"
    }
  },
  "productid": "49281-215_737f89ae-a592-44db-94a4-8a4524ee027f",
  "productndc": "49281-215",
  "dosage_form": "INJECTION, SUSPENSION",
  "dea_schedule": null,
  "product_type": "VACCINE",
  "substance_name": "CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)",
  "proprietary_name": "TENIVAC",
  "active_ingred_unit": "[Lf]/.5mL; [Lf]/.5mL",
  "application_number": "BLA103171",
  "marketing_category": "BLA",
  "nonproprietary_name": "CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) and CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)",
  "start_marketing_date": "20101208",
  "active_numerator_strength": "5; 2"
}

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