Prescription drug · BLA
Tzield (Teplizumab-mzwv) NDC 73650-316
Teplizumab 1 mg/mL · Injection · Intravenous · Provention Bio, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73650-316-01 | 73650031601 | 1 VIAL, SINGLE-DOSE in 1 CARTON (73650-316-01) / 2 mL in 1 VIAL, SINGLE-DOSEMarketed from Nov 17, 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)
- Tzield
- Generic name (nonproprietary)
- teplizumab-mzwv
- Active ingredients
- Teplizumab — 1 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Provention Bio, Inc.NDC labeler code 73650
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761183
- Marketing start
- Listing expires
- Other FDA classes
- CD3-directed Antibody Interactions (Mechanism)
- Identifiers
- Product ID 73650-316_ba0bc7ea-2678-4b1a-9d21-367e2bfd697fSPL ID ba0bc7ea-2678-4b1a-9d21-367e2bfd697fSPL set ID e8a39a5f-139c-4510-9777-71cbb00138faRxCUI 2621885, 2621891UNII S4M959U2IJUPC 0373650316013
- Pharmacologic class
- CD3-directed Antibody
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
N473650031601followed by a unit qualifier and the quantityPackage 73650-0316-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
TZIELD is indicated to [see Dosage and Administration (2.1) ]: Delay the onset of Stage 3 type 1 diabetes (T1D) in adult and pediatric patients 1 year of age and older with Stage 2 T1D. Delay the decline in endogenous insulin production in pediatric patients aged 8 to 17 years recently diagnosed with Stage 3 T1D. This indication is approved under accelerated approval based on evidence of reduced C-peptide decline [see Clinical Studies (14.2) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Limitations of Use: There is limited evidence of safety and effectiveness in patients aged 45 years and older wit…
Excerpt only. Read the full label for complete information.
About NDC 73650-316
- What is NDC 73650-316?
- 73650-316 is the product NDC for Tzield (teplizumab-mzwv), Teplizumab 1 mg/mL injection, listed with the FDA by Provention Bio, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tzield (Teplizumab-mzwv).
- What is the active ingredient?
- Teplizumab.
- Who is the labeler?
- Provention Bio, Inc., NDC labeler code 73650. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tzield?
- 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.