Prescription drug · NDA
Abraxane (Paclitaxel) NDC 68817-134
Paclitaxel 100 mg/20mL · Injection, Powder, Lyophilized, For suspension · Intravenous · Abraxis BioScience, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68817-134-50 | 68817013450 | 1 VIAL, SINGLE-USE in 1 CARTON (68817-134-50) / 20 mL in 1 VIAL, SINGLE-USEMarketed from Feb 10, 2005 |
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)
- Abraxane
- Generic name (nonproprietary)
- paclitaxel
- Active ingredients
- Paclitaxel — 100 mg/20mL
- Dosage form
- Injection, Powder, Lyophilized, For suspension
- Route
- Intravenous
- Labeler
- Abraxis BioScience, LLCNDC labeler code 68817
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021660
- Marketing start
- Listing expires
- Other FDA classes
- Microtubule Inhibition (Physiologic effect)
- Identifiers
- Product ID 68817-134_d1c7770f-7099-4ad3-84e2-20e638cb224eSPL ID d1c7770f-7099-4ad3-84e2-20e638cb224eSPL set ID 24d10449-2936-4cd3-b7db-a7683db721e4RxCUI 583214, 583218UNII P88XT4IS4DUPC 0368817134500
- Pharmacologic class
- Microtubule 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
N468817013450followed by a unit qualifier and the quantityPackage 68817-0134-50. 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)
ABRAXANE is a microtubule inhibitor indicated for the treatment of: • Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. ( 1.1 ) • Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. ( 1.2 ) • Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. ( 1.3 ) 1.1 Metastatic Breast Cancer ABRAXANE is indicated for the treatment …
Excerpt only. Read the full label for complete information.
About NDC 68817-134
- What is NDC 68817-134?
- 68817-134 is the product NDC for Abraxane (paclitaxel), Paclitaxel 100 mg/20mL injection, powder, lyophilized, for suspension, listed with the FDA by Abraxis BioScience, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Abraxane (Paclitaxel).
- What is the active ingredient?
- Paclitaxel.
- Who is the labeler?
- Abraxis BioScience, LLC, NDC labeler code 68817. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Abraxane?
- 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.