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TUBERSOL Tuberculin Purified Protein Derivative 5 [iU]/.1mL Injection, Solution, 1 vial — NDC 49281-0752-21 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

TUBERSOL Tuberculin Purified Protein Derivative 5 [iU]/.1mL Injection, Solution, 1 vial — NDC 49281-752-21 (Billing 49281-0752-21)

by Sanofi Vaccines US Inc. · 1 VIAL, MULTI-DOSE in 1 CARTON / 1 mL in 1 VIAL, MULTI-DOSE

This is a package of 1 vial of TUBERSOL Tuberculin Purified Protein Derivative 5 [iU]/.1mL Injection, Solution from Sanofi Vaccines US Inc., marketed since Aug 1956 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 49281-0752-21
🏷️ FDA NDC (as labeled) 49281-752-21 billing pads the product segment with a zero
This package
Contains1 vial Pack sizes2 compare ↓
Main listing for product 49281-752 · Also comes in: 5 mL 49281-752-22
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 49281-752-21 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
49281 labeler · 752 product · 21 package
Package marketed since
Aug 15, 1956
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 4928175221 6
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 49281-752-21
Product NDC 49281-752
11-digit billing NDC 49281075221
NCPDP billing unit ML — per mL (volume)
RxCUI 313532, 798415
UNII I7L8FKN87J
Application # BLA103941
SPL Set ID a4a732e9-b8ee-4e6d-8b9a-6a9d2c36bfcd
Established class (EPC) Skin Test Antigen; Tuberculosis Skin Test
Physiologic effect Cell-mediated Immunity
Chemical class Antigens, Bacterial
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1956-08-15
Route INTRADERMAL
Dosage form INJECTION, SOLUTION
Substance TUBERCULIN PURIFIED PROTEIN DERIVATIVE
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 94300070002010
GPI class Tubersol
GCN Seq No 009700
GCN 44051
HICL code 004227
Ingredient (HICL) Tuberculin,Purif.prot.deriv.
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W7
Therapeutic class — intermediate (HIC2) Biologicals
HIC3 code W7T
Therapeutic class — specific (HIC3) Antigenic Skin Tests
AHFS code 36:84.00.00
AHFS class Tuberculosis
FDB label name TUBERSOL 5T UNIT/0.1 ML VIAL
FDB brand name Tubersol
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 009700
  • GCN: 44051
  • GPI-14 (Medi-Span): 94300070002010
  • HICL (First Databank): 004227
  • AHFS class code: 36:84.00.00
  • RxCUI (RxNorm): 313532
Why two NDCs? The FDA registers this code as 49281-752-21 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 49281-0752-21. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Tuberculosis Skin Test class.

Pharmacologic class Tuberculosis Skin Test, Skin Test Antigen
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name TUBERSOL 5T UNIT/0.1 ML VIAL Ingredient Tuberculin,Purif.prot.deriv.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 5 mL
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
49281-0752-21 You're viewing this Main listing 1 VIAL, MULTI-DOSE in 1 CARTON / 1 mL in 1 VIAL, MULTI-DOSE 1956-08-15 — Active
49281-0752-22 49281-752-22 1 VIAL, MULTI-DOSE in 1 CARTON / 5 mL in 1 VIAL, MULTI-DOSE 1956-08-15 — Active

Pack size FAQ

What quantity is in this package?
This package contains 1 vial — 1 vial, multi-dose in 1 carton / 1 ml in 1 vial, multi-dose.
What NDC number is used to bill for this package of TUBERSOL Tuberculin Purified Protein Derivative 5 [iU]/.1mL Injection, Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Aplisol 5 [iU]/.1mL 42023-0104-01 ENDO 1 vial $120.453 — Discontinued —
Tubersol 5 [iU]/.1mLthis 49281-0752-21 Sanofi 1 vial — — FDA listed —
Tubersol 5 [iU]/.1mL 50090-0261-00 A-S 1 vial — — FDA listed —
Aplisol 5 [iU]/.1mL 50090-1336-00 A-S 1 vial — — FDA listed —
Tubersol 5 [iU]/.1mL 50090-1668-00 A-S 1 vial — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2000
First FDA approval
Feb 2000
📍
2026
Currently FDA-listed
26 years listed
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 0.35 mg / 0.1 mL UNII 339NCG44TV
    Phenol is a chemical compound derived from coal tar or petroleum. It serves as a preservative and antimicrobial agent in medicines, helping prevent bacterial and fungal growth to keep the product stable and safe during storage.
  • 0.0125 uL / 0.1 mL UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.

2 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerSanofi Vaccines US Inc.
FDA applicationBLA103941 (BLA)
Labeler code49281
First marketedAug 1956
Product typeHuman Prescription Drug
Portfolio27 products on file

More NDCs from Sanofi Vaccines US Inc. labeler code 49281

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 112 words ▾

INDICATIONS AND USAGE TUBERSOL Tuberculin Purified Protein Derivative (Mantoux), is indicated to aid diagnosis of tuberculosis infection (TB) in persons at increased risk of developing active disease. The Centers for Disease Control and Prevention (CDC) have published guidelines regarding populations that would benefit from tuberculin skin testing (TST). Current recommendations can be accessed at: http://www.cdc.gov/tb/publications/factsheets/testing.htm.

Previous BCG vaccination is not a contraindication to tuberculin testing. The skin-test results of BCG vaccinated persons can be used to support or exclude the diagnosis of TB infection. However, an FDA-approved interferon gamma release assay is preferred over tuberculin skin test for persons 5 years of age and older who were previously vaccinated with BCG.

(8)

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Dosage Five (5) tuberculin units (TU) per test dose of 0.1 mL is the standard strength used for intradermal (Mantoux) testing. Method of Administration TUBERSOL is indicated for intradermal injection only. Do not inject intravenously, intramuscularly, or subcutaneously .

If subcutaneous injection occurs, the test cannot be interpreted. Inspect for extraneous particulate matter and/or discoloration before use. If these conditions exist, do not administer the product.

Use a separate syringe and needle for each injection. (12) The following procedure is recommended for performing the Mantoux test: The preferred site of the test is the volar aspect of the forearm. Avoid areas on the skin that are red or swollen.

Avoid visible veins. Clean the skin site with a suitable germicide and allow the site to dry prior to injection of the antigen. Administer the test dose (0.1 mL) of TUBERSOL with a 1 mL syringe calibrated in tenths and fitted with a short, one-quarter to one-half inch, 26 or 27 gauge needle.

Wipe the stopper of the vial with a suitable germicide and allow to dry before needle insertion. Then insert the needle gently through the stopper and draw 0.1 mL of TUBERSOL into the syringe. Avoid injection of excess air with removal of each dose so as not to over pressurize the vial and possibly cause seepage at the puncture site.

Insert the point of the needle into the most superficial layers of the skin with the needle bevel pointing upward and administer the dose by slow intradermal injection . If the intradermal injection is performed properly, a definite pale bleb will rise at the needle point, about 10 mm ( 3 / 8 ") in diameter. This bleb will disperse within minutes.

Do not dress the site. A drop of blood may appear at the administration site following injection. Blot the site lightly to remove the blood but avoid squeezing out the injected tuberculin test fluid.

In the event of an improperly performed injection (i.e., no bleb formed), repeat the test immediately at another site, at least 2 inches from the first site and circle the second injection site as an indication that this is the site to be read. Inform the patient of the need to return for the reading of the test by a trained health professional. Self-reading may be inaccurate and is strongly discouraged.

Interpretation of the Test The skin test should be read by a trained health professional 48 to 72 hours after administration of TUBERSOL. Skin test sensitivity is indicated by induration only; redness should not be measured. Measure the diameter of induration transversely to the long axis of the forearm and record the measurement in millimeters (including 0 mm).

(7) The tip of a ballpoint pen, gently pushed at a 45° angle toward the site of injection, will stop at the edge of induration. Also record presence and size (if present) of necrosis and edema, although these are not used in the interpretation of the test. Positive Reactions Tuberculin reactivity may indicate latent infection, prior infection and/or disease with M. tuberculosis and does not necessarily indicate the presence of active tuberculous disease.

Persons showing positive tuberculin reactions should be considered positive by current public health guidelines and referred for further medical evaluation. (7)(9) The repeated testing of uninfected persons does not sensitize them to TUBERSOL. (6)(7)(9) The significance of induration measurements in diagnosing latent TB infection must be considered in terms of the patient's history and the risk of developing active TB disease as indicated in Table 1.

(9) Table 1: Criteria for tuberculin positivity, by risk group Reaction ≥5 mm of Induration Reaction ≥10 mm of Induration Reaction ≥15 mm of Induration HIV-positive persons Recent contacts of tuberculosis (TB) case patients Fibrotic changes on chest radiograph consistent with prior TB Patients with organ transplants and other immunosuppressed patients (receiving the equivalent of ≥15 mg/… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 82 words ▾

CONTRAINDICATIONS Allergy to any component of TUBERSOL or an anaphylactic or other allergic reaction to a previous test of tuberculin PPD is a contraindication to the use of TUBERSOL. (See DESCRIPTION and HOW SUPPLIED .) TUBERSOL should not be administered to: Persons who have had a severe reaction (e.g., necrosis, blistering, anaphylactic shock, or ulcerations) to a previous TST, Persons with documented active tuberculosis or a clear history of treatment for TB infection or disease, (9) Persons with extensive burns or eczema.

⚠️ Warnings 74 words ▾

WARNINGS Hypersensitivity Allergic reactions may occur following the use of TUBERSOL even in persons with no prior history of hypersensitivity to the product components. (10) Epinephrine injection (1:1,000) and other appropriate agents used for the control of immediate allergic reactions must be immediately available. Syncope Syncope (fainting) can occur in association with administration of injectable medicines, including TUBERSOL.

Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

🤒 Adverse Reactions 207 words ▾

ADVERSE REACTIONS Induration at the TUBERSOL injection site is the expected reaction for a positive skin test. (See Interpretation of the Test .) The information pertaining to adverse events has been compiled from historical clinical studies and post-marketing experience with TUBERSOL. General disorders and administration site conditions Injection site pain, injection site pruritus and injection site discomfort.

Injection site erythema or injection site rash (without induration) occurring within 12 hours of testing. These reactions do not indicate TB infection. Injection site hemorrhage and injection site hematoma up to three days after the administration of the test.

Injection site vesicles, injection site ulcer or injection site necrosis in highly sensitive persons. Injection site scar as a result of strongly positive reactions. Pyrexia Immune system disorders Hypersensitivity, including anaphylaxis/anaphylactic reactions, angioedema, urticaria Respiratory, thoracic, and mediastinal disorders Stridor, dyspnea Skin and subcutaneous tissue disorders Rash, generalized rash Nervous system disorders Presyncope, syncope (including syncope associated with tonic-clonic movements and other seizure-like activity) sometimes resulting in transient loss of consciousness with injury Reporting of Adverse Events To report SUSPECTED ADVERSE REACTIONS, contact the Pharmacovigilance Department, Sanofi Vaccines US Inc., Discovery Drive, Swiftwater, PA 18370 or call 1-800-822-2463 (1-800-VACCINE) or Food and Drug Administration (FDA) MEDWATCH Program at 1-800-332-1088 and www.fda.gov/medwatch.

🔄 Drug Interactions 104 words ▾

Drug Interactions Reactivity to the test may be depressed or suppressed in persons who are receiving corticosteroids or immunosuppressive agents. (7) Reactivity to TUBERSOL may be temporarily depressed by certain live virus vaccines (measles, mumps, rubella, oral polio, yellow fever, and varicella). If a parenteral live attenuated virus vaccine has been administered recently, tuberculin testing should be delayed for >1 month after vaccination.

(7)(11) (See Interpretation of the Test .) When tuberculin screening is required at the same time as a measles-containing vaccine or other parenteral live attenuated virus vaccine, simultaneous administration of TUBERSOL and the vaccine at separate sites is the preferred option.

🤰 Pregnancy 44 words ▾

Pregnancy Animal reproduction studies have not been conducted with TUBERSOL. It is also not known whether TUBERSOL can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. TUBERSOL should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 35 words ▾

Pediatric Use There is no contraindication to tuberculin skin testing of infants. Infants <6 months of age who are infected with M . tuberculosis may not react to TUBERSOL. (See Interpretation of the Test .)

🧓 Geriatric Use 26 words ▾

Geriatric Use Clinical studies of TUBERSOL did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🧬 Clinical Pharmacology 159 words ▾

CLINICAL PHARMACOLOGY Mechanism of Action The sensitization following infection with mycobacteria occurs primarily in the regional lymph nodes. Small lymphocytes (T lymphocytes) proliferate in response to the antigenic stimulus to give rise to specifically sensitized lymphocytes. After 3-8 weeks, these lymphocytes enter the blood stream and circulate for years.

(6) Subsequent restimulation of these sensitized lymphocytes with the same or a similar antigen, such as the intradermal injection of TUBERSOL, evokes a local reaction mediated by these cells. (7) Characteristically, delayed hypersensitivity reactions to tuberculin begin at 5 to 6 hours, are maximal at 48 to 72 hours and subside over a period of days. The resultant immune response consists of induration due to cell infiltration and occasionally vesiculation and necrosis.

Clinically, a delayed hypersensitivity reaction to tuberculin is a manifestation of previous infection with M tuberculosis or a variety of non-tuberculosis bacteria. In most cases sensitization is induced by natural mycobacterial infection or by vaccination with BCG Vaccine.

🧬 Mechanism of Action 157 words ▾

Mechanism of Action The sensitization following infection with mycobacteria occurs primarily in the regional lymph nodes. Small lymphocytes (T lymphocytes) proliferate in response to the antigenic stimulus to give rise to specifically sensitized lymphocytes. After 3-8 weeks, these lymphocytes enter the blood stream and circulate for years.

(6) Subsequent restimulation of these sensitized lymphocytes with the same or a similar antigen, such as the intradermal injection of TUBERSOL, evokes a local reaction mediated by these cells. (7) Characteristically, delayed hypersensitivity reactions to tuberculin begin at 5 to 6 hours, are maximal at 48 to 72 hours and subside over a period of days. The resultant immune response consists of induration due to cell infiltration and occasionally vesiculation and necrosis.

Clinically, a delayed hypersensitivity reaction to tuberculin is a manifestation of previous infection with M tuberculosis or a variety of non-tuberculosis bacteria. In most cases sensitization is induced by natural mycobacterial infection or by vaccination with BCG Vaccine.

📦 How Supplied / Storage and Handling 145 words ▾

HOW SUPPLIED TUBERSOL Tuberculin Purified Protein Derivative (Mantoux), bioequivalent to 5 US units (TU) PPD-S per test dose (0.1 mL) is supplied in: 1 mL multi-dose vial (10 tests). NDC No. 49281-752-78; package of 1 vial, NDC No.

49281-752-21 5 mL multi-dose vial (50 tests). NDC No. 49281-752-98; package of 1 vial, NDC No.

49281-752-22 The stopper of the vial for this product does not contain natural latex rubber. STORAGE Store at 2° to 8°C (35° to 46°F). (19) Do not freeze.

Discard product if exposed to freezing. Protect from light. Tuberculin PPD solutions can be adversely affected by exposure to light.

The product should be stored in the dark except when doses are actually being withdrawn from the vial. (20) A vial of TUBERSOL which has been entered and in use for 30 days should be discarded. (21) Do not use after expiration date.

📦 Storage and Handling 76 words ▾

STORAGE Store at 2° to 8°C (35° to 46°F). (19) Do not freeze. Discard product if exposed to freezing. Protect from light. Tuberculin PPD solutions can be adversely affected by exposure to light. The product should be stored in the dark except when doses are actually being withdrawn from the vial. (20) A vial of TUBERSOL which has been entered and in use for 30 days should be discarded. (21) Do not use after expiration date.

📋 Description 169 words ▾

DESCRIPTION TUBERSOL ® Tuberculin Purified Protein Derivative (Mantoux) (PPD) (1) for intradermal tuberculin testing is prepared from a large Master Batch Connaught Tuberculin (CT68) (2) and is a cell-free purified protein fraction obtained from a human strain of Mycobacterium tuberculosis grown on a protein-free synthetic medium and inactivated. (2) The use of a standard preparation derived from a single batch (CT68) has been adopted in order to eliminate batch to batch variation by the same manufacturer. (2) TUBERSOL is a clear, colorless liquid.

TUBERSOL contains: Purified protein derivative of M. tuberculosis 5 TU per 0.1 mL Polysorbate 80 0.0006% Phenol 0.22% to 0.35% w/v in sterile isotonic phosphate buffered saline. Before release, each successive lot is tested for potency in comparison with a reference standard. Independent studies conducted by the US Public Health Service in humans have determined the amount of CT68 in stabilized solution necessary (3)(4)(5) to produce bio-equivalency with Tuberculin PPD-S (in phosphate buffer without polysorbate 80) using 5 US units (TU) Tuberculin PPD-S as the standard.

💬 Information for Patients 139 words ▾

Information for Patients Prior to administration of TUBERSOL, the patient's current health status and medical history should be reviewed. The physician should review the patient's immunization history for possible sensitivity to components of TUBERSOL. The healthcare provider should inform the patient of the need to return for the reading of the test.

Self-reading of the test has been shown to be inaccurate and unreliable. The healthcare provider should give the patient a permanent personal record. In addition, it is essential that the health professional record the testing history in the permanent medical record of each patient.

This permanent office record should contain the name of the product, date given, dose, manufacturer, and lot number, as well as the test result in millimeters of induration (including 0 mm, if appropriate). Reporting results only as negative or positive is not satisfactory.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General Diagnostic Limitations False positive or false negative tuberculin skin test reactions may occur in some individuals. (See Interpretation of the Test .) False positive tuberculin reaction tests occur in individuals who have been infected with other mycobacteria, including vaccination with BCG. Not all infected persons will have a delayed hypersensitivity reaction to a tuberculin test.

Many factors have been reported to cause a decreased ability to respond to the tuberculin test in the presence of tuberculous infection. (See Interpretation of the Test .) Information for Patients Prior to administration of TUBERSOL, the patient's current health status and medical history should be reviewed. The physician should review the patient's immunization history for possible sensitivity to components of TUBERSOL.

The healthcare provider should inform the patient of the need to return for the reading of the test. Self-reading of the test has been shown to be inaccurate and unreliable. The healthcare provider should give the patient a permanent personal record.

In addition, it is essential that the health professional record the testing history in the permanent medical record of each patient. This permanent office record should contain the name of the product, date given, dose, manufacturer, and lot number, as well as the test result in millimeters of induration (including 0 mm, if appropriate). Reporting results only as negative or positive is not satisfactory.

Drug Interactions Reactivity to the test may be depressed or suppressed in persons who are receiving corticosteroids or immunosuppressive agents. (7) Reactivity to TUBERSOL may be temporarily depressed by certain live virus vaccines (measles, mumps, rubella, oral polio, yellow fever, and varicella). If a parenteral live attenuated virus vaccine has been administered recently, tuberculin testing should be delayed for >1 month after vaccination.

(7)(11) (See Interpretation of the Test .) When tuberculin screening is required at the same time as a measles-containing vaccine or other parenteral live attenuated virus vaccine, simultaneous administration of TUBERSOL and the vaccine at separate sites is the preferred option. CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY TUBERSOL has not been evaluated for its carcinogenic or mutagenic potentials or impairment of fertility. Pregnancy Animal reproduction studies have not been conducted with TUBERSOL.

It is also not known whether TUBERSOL can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. TUBERSOL should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether TUBERSOL is excreted in human milk.

Because many drugs are excreted in human milk, caution should be exercised when TUBERSOL is administered to a nursing woman. Pediatric Use There is no contraindication to tuberculin skin testing of infants. Infants <6 months of age who are infected with M . tuberculosis may not react to TUBERSOL.

(See Interpretation of the Test .) Geriatric Use Clinical studies of TUBERSOL did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🍼 Nursing Mothers 33 words ▾

Nursing Mothers It is not known whether TUBERSOL is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TUBERSOL is administered to a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 20 words ▾

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY TUBERSOL has not been evaluated for its carcinogenic or mutagenic potentials or impairment of fertility.

📚 References ~2 min read ▾

REFERENCES 1 Landi S. Preparation, purification, and stability of tuberculin. Appl Microbiol 1963;11:408-412.

2 Landi S, et al. Preparation and characterization of a large batch of tuberculin purified protein derivative (PPD-CT68). Ann Scalvo.1980;22:889-907.

3 Landi S, et al. Adsorption of tuberculin PPD to glass and plastic surfaces. Bull.

WHO 1966;35:593-602. 4 Landi S, et al. Disparity of potency between stabilized and nonstabilized dilute tuberculin solutions.

Am Rev Respir Dis 1971;104:385-393. 5 Landi S, et al. Stability of dilute solutions of tuberculin purified protein derivative.

Tubercle 1978;59:121-133. 6 Menzies D. Interpretation of repeated tuberculin tests.

Am J Respir Crit Care Med 1999;159:15-21. 7 American Thoracic Society: Diagnostic standards and classification of tuberculosis in adults and children. Am J Respir Crit Care Med 2000;161:1376-1395.

8 CDC. Updated Guidelines for Using Interferon Gamma Release Assays to Detect Mycobacterium tuberculosis Infection - United States, 2010. MMWR 2010; 59 (RR-5):1-25.

9 CDC. Targeted tuberculin testing and treatment of latent tuberculosis infection. MMWR 2000;49(RR-6):23-5.

10 Froeschle JE, et al. Immediate hypersensitivity reactions after use of tuberculin skin testing. Clin Infect Dis 2002;34:e12-13.

11 Brickman HF, et al. The timing of tuberculin tests in relation to immunization with live viral vaccines. Pediatrics: 1975;55:392-396.

12 CDC. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). MMWR 2002;51(RR-2):1-36.

13 CDC. Guidelines for preventing the transmission of Mycobacterium tuberculosis in health-care settings, 2005. MMWR 2005;54(RR-17):1-141.

14 CDC. The role of BCG vaccine in the prevention and control of tuberculosis in the United States. A joint statement by the Advisory Council for the Elimination of Tuberculosis and the Advisory Committee on Immunization Practices.

MMWR 1996; 45(RR-4):1-18. 15 CDC. Guidelines for the Investigation of Contacts of Persons with Infectious Tuberculosis: Recommendations from the National Tuberculosis Controllers Association and CDC.

MMWR 2005;54(RR-15):1-37. 16 Mori and Shiozawa. Suppression of tuberculin hypersensitivity caused by rubella infection.

Am Rev Respir Dis 1985;886-888. 17 CDC. Guidelines for prevention and treatment of opportunistic infections in HIV-infected adults and adolescents.

Recommendations from the CDC, the National Institutes of Health, and the HIV Medicine Association of Infectious Diseases Society of America. MMWR 2009;58(RR-4):1-207. 18 CDC.

Prevention and control of tuberculosis in correctional and detention facilities: Recommendations from the CDC. MMWR 2006;55(RR-9):1-44. 19 Landi S, et al.

Stability of dilute solution of tuberculin purified protein derivative at extreme temperatures. J Biol Stand 1981;9:195-199. 20 Landi S, et al.

Effect of light on tuberculin purified protein derivative solutions. Am Rev Respir Dis 1975;111:52-61. 21 Landi S, et al.

Effect of oxidation on the stability of tuberculin purified protein derivative (PPD) In: International Symposium on Tuberculins and BCG Vaccine. Basel: International Association of Biological Standardization, 1983. Dev Biol Stand 1986;58:545-552.

📄 Package Label / Principal Display Panel 192 words ▾

PRINCIPAL DISPLAY PANEL - 1 mL Vial Label Tuberculin Purified Protein Derivative (Mantoux) TUBERSOL ® Multi-dose vial 1 mL (10 Tests) Test dose: 5 TU/0.1 mL ID. Protect from light. Discard opened product after 30 days. Rx only Sanofi Pasteur Limited PRINCIPAL DISPLAY PANEL - 1 mL Vial Label

PRINCIPAL DISPLAY PANEL - 1 mL Vial Carton NDC 49281-752-21 PPD Tuberculin Purified Protein Derivative (Mantoux) TUBERSOL ® Tween Stabilized Solution Test dose: 5 TU/0.1 mL intradermally. Multi-dose vial (10 Tests) 5 Tuberculin units per test Rx only sanofi PRINCIPAL DISPLAY PANEL - 1 mL Vial Carton

PRINCIPAL DISPLAY PANEL - 5 mL Vial Label Tuberculin Purified Protein Derivative (Mantoux) TUBERSOL ® Multi-dose vial 5 mL (50 Tests) Test dose: 5 TU/0.1 mL ID. Protect from light. Discard opened product after 30 days. Rx only Sanofi Pasteur Limited PRINCIPAL DISPLAY PANEL - 5 mL Vial Label

PRINCIPAL DISPLAY PANEL - 5 mL Vial Carton NDC 49281-752-22 PPD Tuberculin Purified Protein Derivative (Mantoux) TUBERSOL ® Tween Stabilized Solution Rx only Test dose: 5 TU/0.1 mL intradermally. Multi-dose vial (50 Tests) 5 Tuberculin units per test sanofi PRINCIPAL DISPLAY PANEL - 5 mL Vial Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Sanofi Vaccines US Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 vial (49281-0752-22). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Sanofi Vaccines US Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 49281-0726-10 · Sanofi 49281-0790-20 · Sanofi →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.