Product Specifications
| Specification | 1 mL Vial Option (10 Tests) | 5 mL Vial Option (50 Tests) |
| Manufacturer / Brand | Sanofi Pasteur Limited / TUBERSOL® | Sanofi Pasteur Limited / TUBERSOL® |
| Manufacturer SKU / Item # | 49281075221 | 49281075222 |
| NDC Number | 49281-752-21 | 49281-752-22 |
| Active Ingredient | Tuberculin Purified Protein Derivative (PPD) | Tuberculin Purified Protein Derivative (PPD) |
| Strength / Dosage | 5 Tuberculin Units (TU) per 0.1 mL dose | 5 Tuberculin Units (TU) per 0.1 mL dose |
| Total Content per Vial | 1 mL (Up to 10 tests) | 5 mL (Up to 50 tests) |
| Container Type | Glass Multiple-Dose Vial (MDV) | Glass Multiple-Dose Vial (MDV) |
| Administration Route | Intradermal (ID) (Mantoux Technique) | Intradermal (ID) (Mantoux Technique) |
| Formulation | Phenol-Preserved (0.35%) / Polysorbate 80 | Phenol-Preserved (0.35%) / Polysorbate 80 |
| Storage Temperature | 2°C to 8°C (36°F to 46°F) (Refrigerate) | 2°C to 8°C (36°F to 46°F) (Refrigerate) |
| Packaging Configuration | 1 Vial per Box | 1 Vial per Box |
| Regulatory Category | Prescription-Only (Rx) / BLA103913 | Prescription-Only (Rx) / BLA103913 |
Key Features & Clinical Applications
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Standardized Mantoux Skin Testing: Indicated as a diagnostic aid to detect latent or active infection with Mycobacterium tuberculosis in adults and pediatric populations.
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Master-Batch Consistency: Formulated from a single master batch of tuberculin (PPD-S equivalent) to ensure standardized reactivity and eliminate batch-to-batch variation in induration reading.
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Polysorbate 80 Stabilized: Contains Tween-80 (Polysorbate 80) as a stabilizing agent to prevent adsorption of the protein derivative to glass vial surfaces and syringe walls.
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Flexible Clinic Packaging: Available in compact 1 mL (10-test) vials for low-volume clinics or high-capacity 5 mL (50-test) vials for high-volume occupational health screening, employee health departments, and public health facilities.
⚠️ Administration Requirement: Administer strictly via intradermal injection (Mantoux method) using a tuberculin syringe and 26- or 27-gauge needle. Do not administer subcutaneously or intravenously. Subcutaneous injection results in a false-negative or uninterpretable reading.
⚠️ Reading Window: The test must be read by a trained healthcare professional 48 to 72 hours post-administration by measuring the transverse diameter of induration (palpable swelling) in millimeters, not erythema.
⚠️ Contraindications: Contraindicated in patients with known hypersensitivity to tuberculin PPD, prior severe local reaction (e.g., necrosis, blistering, ulceration) to a tuberculin skin test, or documented active tuberculosis infection.



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