Prescription drug · BLA
Trazimera (Trastuzumab-qyyp) NDC 0069-0305
Kit · Pfizer Laboratories Div Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0069-0305-01 | 00069030501 | 1 KIT in 1 KIT (0069-0305-01) * 20 mL in 1 VIAL, MULTI-DOSE (0069-0306-01) * 20 mL in 1 VIAL (0069-0307-01)Marketed from Feb 24, 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)
- Trazimera
- Generic name (nonproprietary)
- trastuzumab-qyyp
- Dosage form
- Kit
- Labeler
- Pfizer Laboratories Div Pfizer IncNDC labeler code 0069
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761081
- Marketing start
- Listing expires
- Identifiers
- Product ID 0069-0305_6bb3d11b-6f9e-408c-a957-b7bacaf9e175SPL ID 6bb3d11b-6f9e-408c-a957-b7bacaf9e175SPL set ID b9c5e894-27d2-4245-a653-df986fed3c56RxCUI 2280732, 2280737, 2472791, 2472794UNII P188ANX8CK
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.
- NDC on a medical claim
N400069030501followed by a unit qualifier and the quantityPackage 00069-0305-01. 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)
TRAZIMERA is a HER2/neu receptor antagonist indicated in adults for: • The treatment of HER2-overexpressing breast cancer. ( 1.1 , 1.2 ) • The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. ( 1.3 ) Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product. ( 1 , 2.2 ) 1.1 Adjuvant Breast Cancer TRAZIMERA is indicated in adults for adjuvant treatment of HER2-overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see Clinical Studies (14.1) ] ) breast cancer • as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or doceta…
Excerpt only. Read the full label for complete information.
About NDC 0069-0305
- What is NDC 0069-0305?
- 0069-0305 is the product NDC for Trazimera (trastuzumab-qyyp) kit, 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?
- Trazimera (Trastuzumab-qyyp).
- 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 Trazimera?
- 1 other product NDC are listed under this name. See all Trazimera NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Trazimera products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Trazimeratrastuzumab-qyyp | Trastuzumab 150 mg/7.15mL | Injection, Powder, Lyophilized, For solutionIntravenous | Pfizer Laboratories Div Pfizer Inc | 0069-0308 | 00069-0308-01 |
Other NDCs under BLA 761081
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 |
|---|---|---|---|---|
| Trazimeratrastuzumab-qyyp | Trastuzumab 150 mg/7.15mL | Injection, Powder, Lyophilized, For solutionIntravenous | Pfizer Laboratories Div Pfizer Inc | 0069-0308 |