Prescription drug · BLA
Ziihera (Zanidatamab-hrii) NDC 68727-950
Zanidatamab 50 mg/mL · Injection, Powder, Lyophilized, For solution · Intravenous · Jazz Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68727-950-02 | 68727095002 | 2 VIAL, SINGLE-DOSE in 1 CARTON (68727-950-02) / 6 mL in 1 VIAL, SINGLE-DOSE (68727-950-01)Marketed from Nov 20, 2024 |
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)
- Ziihera
- Generic name (nonproprietary)
- zanidatamab-hrii
- Active ingredients
- Zanidatamab — 50 mg/mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Jazz Pharmaceuticals, Inc.NDC labeler code 68727
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761416
- Marketing start
- Listing expires
- Other FDA classes
- HER2-directed Antibody Interactions (Mechanism)
- Identifiers
- Product ID 68727-950_526942b1-adcb-4202-82ab-3d5eaaefc812SPL ID 526942b1-adcb-4202-82ab-3d5eaaefc812SPL set ID ae5d9425-fae5-4541-a158-150998343348RxCUI 2698206, 2698212UNII Z20OC92TDI
- Pharmacologic class
- Bispecific HER2-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
N468727095002followed by a unit qualifier and the quantityPackage 68727-0950-02. 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)
ZIIHERA is a bispecific HER2-directed antibody indicated for: Gastroesophageal Adenocarcinoma (GEA) • in combination with fluoropyrimidine- and platinum-containing chemotherapy, and tislelizumab-jsgr, as first-line treatment of adult patients with HER2-positive (IHC 3+ or IHC 2+/ISH+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, as detected by an FDA-authorized test. ( 1.1 ) • in combination with fluoropyrimidine- and platinum-containing chemotherapy, as first-line treatment of adult patients with HER2-positive (IHC 3+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma,…
Excerpt only. Read the full label for complete information.
About NDC 68727-950
- What is NDC 68727-950?
- 68727-950 is the product NDC for Ziihera (zanidatamab-hrii), Zanidatamab 50 mg/mL injection, powder, lyophilized, for solution, listed with the FDA by Jazz Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ziihera (Zanidatamab-hrii).
- What is the active ingredient?
- Zanidatamab.
- Who is the labeler?
- Jazz Pharmaceuticals, Inc., NDC labeler code 68727. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ziihera?
- 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.