Prescription drug · BLA
Tubersol (Tuberculin purified protein derivative) NDC 50090-0261
Tuberculin purified protein derivative 5 [iU]/.1mL · Injection, Solution · Intradermal · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-0261-0 | 50090026100 | 1 VIAL, MULTI-DOSE in 1 CARTON (50090-0261-0) / 1 mL in 1 VIAL, MULTI-DOSEMarketed from Jun 29, 2016 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Tubersol
- Generic name (nonproprietary)
- tuberculin purified protein derivative
- Active ingredients
- Tuberculin purified protein derivative — 5 [iU]/.1mL
- Dosage form
- Injection, Solution
- Route
- Intradermal
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103941
- Marketing start
- Listing expires
- Other FDA classes
- Bacterial (Chemical structure)Cell-mediated Immunity (Physiologic effect)
- Identifiers
- Product ID 50090-0261_d88c50ba-fe16-4d39-8c61-42549f200d67SPL ID d88c50ba-fe16-4d39-8c61-42549f200d67SPL set ID 261efc52-a105-4c2c-a8ce-9eee20b62efcRxCUI 313532, 798415UNII I7L8FKN87J
- Pharmacologic class
- Skin Test Antigen; Tuberculosis Skin Test
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N450090026100followed by a unit qualifier and the quantityPackage 50090-0261-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
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 ass…
Excerpt only. Read the full label for complete information.
About NDC 50090-0261
- What is NDC 50090-0261?
- 50090-0261 is the product NDC for Tubersol (tuberculin purified protein derivative), Tuberculin purified protein derivative 5 [iU]/.1mL injection, solution, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tubersol (Tuberculin Purified Protein Derivative).
- What is the active ingredient?
- Tuberculin purified protein derivative.
- Who is the labeler?
- A-S Medication Solutions, NDC labeler code 50090. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tubersol?
- 2 other product NDCs are listed under this name. See all Tubersol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tubersol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tubersoltuberculin purified protein derivative | Tuberculin purified protein derivative 5 [iU]/.1mL | Injection, SolutionIntradermal | Sanofi Vaccines US Inc. | 49281-752 | 49281-0752-2149281-0752-22 |
| Tubersoltuberculin purified protein derivative | Tuberculin purified protein derivative 5 [iU]/.1mL | Injection, SolutionIntradermal | A-S Medication Solutions | 50090-1668 | 50090-1668-00 |
Other NDCs under BLA 103941
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Tubersoltuberculin purified protein derivative | Tuberculin purified protein derivative 5 [iU]/.1mL | Injection, SolutionIntradermal | Sanofi Vaccines US Inc. | 49281-752 |
| Tubersoltuberculin purified protein derivative | Tuberculin purified protein derivative 5 [iU]/.1mL | Injection, SolutionIntradermal | A-S Medication Solutions | 50090-1668 |