Prescription drug · BLA
Tepezza (Teprotumumab) NDC 75987-130
Teprotumumab 500 mg/1 · Injection, Powder, Lyophilized, For solution · Intravenous · Horizon Therapeutics USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 75987-130-15 | 75987013015 | 1 VIAL, SINGLE-DOSE in 1 CARTON (75987-130-15) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSEMarketed from Jan 21, 2020 |
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)
- Tepezza
- Generic name (nonproprietary)
- teprotumumab
- Active ingredients
- Teprotumumab — 500 mg/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Horizon Therapeutics USA, Inc.NDC labeler code 75987
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761143
- Marketing start
- Listing expires
- Other FDA classes
- Insulin-like Growth Factor-1 Receptor Inhibitors (Mechanism)
- Identifiers
- Product ID 75987-130_2fea590d-9312-4134-968c-fa9032d09f76SPL ID 2fea590d-9312-4134-968c-fa9032d09f76SPL set ID 3e6c54a1-cefd-4a5b-a855-ab9f268b6cceRxCUI 2274807, 2274812UNII Y64GQ0KC0A
- Pharmacologic class
- Insulin-like Growth Factor-1 Receptor 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
N475987013015followed by a unit qualifier and the quantityPackage 75987-0130-15. 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)
TEPEZZA is indicated for the treatment of Thyroid Eye Disease regardless of Thyroid Eye Disease activity or duration. TEPEZZA is an insulin-like growth factor-1 receptor inhibitor indicated for the treatment of Thyroid Eye Disease ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 75987-130
- What is NDC 75987-130?
- 75987-130 is the product NDC for Tepezza (teprotumumab), Teprotumumab 500 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by Horizon Therapeutics USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tepezza (Teprotumumab).
- What is the active ingredient?
- Teprotumumab.
- Who is the labeler?
- Horizon Therapeutics USA, Inc., NDC labeler code 75987. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tepezza?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.