Prescription drug · NDA
Tpoxx (Tecovirimat monohydrate) NDC 50072-010
Tecovirimat 10 mg/mL · Injection, Solution, Concentrate · Intravenous · SIGA Technologies, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50072-010-01 | 50072001001 | 7 VIAL in 1 CARTON (50072-010-01) / 20 mL in 1 VIAL (50072-010-30)Marketed from May 31, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Tpoxx
- Generic name (nonproprietary)
- tecovirimat monohydrate
- Active ingredients
- Tecovirimat — 10 mg/mL
- Dosage form
- Injection, Solution, Concentrate
- Route
- Intravenous
- Labeler
- SIGA Technologies, Inc.NDC labeler code 50072
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 214518
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 2C8 Inhibitors (Mechanism)Cytochrome P450 3A Inducers (Mechanism)
- Identifiers
- Product ID 50072-010_474526fb-5357-880e-e063-6294a90a3296SPL ID 474526fb-5357-880e-e063-6294a90a3296SPL set ID fce826ab-4d6a-4139-a2ee-a304a913a253RxCUI 2055109, 2055115, 2602126, 2602131UNII SB96YO2BR8, F925RR824RUPC 0350072010309, 0350072200427
- Pharmacologic class
- Orthopoxvirus VP37 Envelope Wrapping Protein Inhibitor
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
N450072001001followed by a unit qualifier and the quantityPackage 50072-0010-01. 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)
TPOXX is an inhibitor of the orthopoxvirus VP37 envelope wrapping protein and is indicated for the treatment of human smallpox disease in adults and pediatric patients weighing at least 3 kg. ( 1.1 ) Limitations of Use: The effectiveness of TPOXX for treatment of smallpox disease has not been determined in humans because adequate and well-controlled field trials have not been feasible, and inducing smallpox disease in humans to study the drug’s efficacy is not ethical. ( 1.2 ) TPOXX efficacy may be reduced in immunocompromised patients based on studies demonstrating reduced efficacy in immunocompromised animal models. ( 1.2 ) 1.1 Treatment of Human Smallpox Disease TPOXX ® is indicated for t…
Excerpt only. Read the full label for complete information.
About NDC 50072-010
- What is NDC 50072-010?
- 50072-010 is the product NDC for Tpoxx (tecovirimat monohydrate), Tecovirimat 10 mg/mL injection, solution, concentrate, listed with the FDA by SIGA Technologies, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tpoxx (Tecovirimat monohydrate).
- What is the active ingredient?
- Tecovirimat.
- Who is the labeler?
- SIGA Technologies, Inc., NDC labeler code 50072. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tpoxx?
- 1 other product NDC are listed under this name. See all Tpoxx NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tpoxx products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tpoxxtecovirimat monohydrate | Tecovirimat monohydrate 200 mg/1 | CapsuleOral | SIGA Technologies, Inc. | 50072-200 | 50072-0200-42 |