Prescription drug · BLA
Zirabev (Bevacizumab-bvzr) NDC 0069-0342
Bevacizumab 400 mg/16mL · Injection, Solution · Intravenous · Pfizer Laboratories Div Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0069-0342-01 | 00069034201 | 1 VIAL, SINGLE-USE in 1 CARTON (0069-0342-01) / 16 mL in 1 VIAL, SINGLE-USEMarketed from Jan 13, 2020 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Zirabev
- Generic name (nonproprietary)
- bevacizumab-bvzr
- Active ingredients
- Bevacizumab — 400 mg/16mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Pfizer Laboratories Div Pfizer IncNDC labeler code 0069
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761099
- Marketing start
- Listing expires
- Other FDA classes
- Vascular Endothelial Growth Factor Inhibitors (Mechanism)Vascular Endothelial Growth Factor-directed Antibody Interactions (Mechanism)
- Identifiers
- Product ID 0069-0342_8f385b9e-2699-46a0-8c5f-ec1d86cd609dSPL ID 8f385b9e-2699-46a0-8c5f-ec1d86cd609dSPL set ID aa27acbd-d117-4350-aeee-17bc2e2c0ca4RxCUI 2268039, 2268044, 2268047, 2268048UNII 2S9ZZM9Q9VUPC 0300690342016
- Pharmacologic class
- Vascular Endothelial Growth Factor 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 codeMed-Code curated
J9035 — Injection, bevacizumab, 10 mg
Billing unit: 10 mg. Units on the claim = dose given ÷ 10 mg.
Bevacizumab biosimilars have their own HCPCS codes.
- 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
N400069034201followed by a unit qualifier and the quantityPackage 00069-0342-01. 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)
ZIRABEV is a vascular endothelial growth factor inhibitor indicated for the treatment of: • Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment. ( 1.1 ) • Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. ( 1.1 ) Limitations of Use : ZIRABEV is not indicated for adjuvant treatment of colon cancer. ( 1.1 ) • Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with ca…
Excerpt only. Read the full label for complete information.
About NDC 0069-0342
- What is NDC 0069-0342?
- 0069-0342 is the product NDC for Zirabev (bevacizumab-bvzr), Bevacizumab 400 mg/16mL injection, solution, listed with the FDA by Pfizer Laboratories Div Pfizer Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zirabev (Bevacizumab-bvzr).
- What is the active ingredient?
- Bevacizumab.
- Who is the labeler?
- Pfizer Laboratories Div Pfizer Inc, NDC labeler code 0069. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zirabev?
- 1 other product NDC are listed under this name. See all Zirabev NDCs.
- Is there a related HCPCS / J-code?
- Yes: J9035, Injection, bevacizumab, 10 mg. See Billing references above.
Related NDCs: other Zirabev products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zirabevbevacizumab-bvzr | Bevacizumab 100 mg/4mL | Injection, SolutionIntravenous | Pfizer Laboratories Div Pfizer Inc | 0069-0315 | 00069-0315-01 |
Other NDCs under BLA 761099
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 |
|---|---|---|---|---|
| Zirabevbevacizumab-bvzr | Bevacizumab 100 mg/4mL | Injection, SolutionIntravenous | Pfizer Laboratories Div Pfizer Inc | 0069-0315 |