Prescription drug · ANDA
Paclitaxel 100mg per vial (paclitaxel protein-bound particles) NDC 76282-768
Paclitaxel 100 mg/20mL · Injection, Powder, Lyophilized, For suspension · Intravenous · EXELAN PHARMACEUTICALS INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76282-768-09 | 76282076809 | 1 VIAL, SINGLE-DOSE in 1 CARTON (76282-768-09) / 20 mL in 1 VIAL, SINGLE-DOSEMarketed from Aug 11, 2026 |
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)
- Paclitaxel 100mg per vial
- Generic name (nonproprietary)
- paclitaxel protein-bound particles
- Active ingredients
- Paclitaxel — 100 mg/20mL
- Dosage form
- Injection, Powder, Lyophilized, For suspension
- Route
- Intravenous
- Labeler
- EXELAN PHARMACEUTICALS INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209657
- Marketing start
- Listing expires
- Other FDA classes
- Microtubule Inhibition (Physiologic effect)
- Identifiers
- Product ID 76282-768_94c07774-2008-4ba9-bc92-1c723dcc5b25SPL ID 94c07774-2008-4ba9-bc92-1c723dcc5b25SPL set ID 135502ff-002c-4a29-ba93-60855cf44f31RxCUI 583214UNII P88XT4IS4DUPC 0376282768090
- 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
N476282076809followed by a unit qualifier and the quantityPackage 76282-0768-09. 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)
Paclitaxel 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 Paclitaxel protein-bound particles for injec…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209657
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 |
|---|---|---|---|---|
| Paclitaxel protein-bound particles | Paclitaxel 100 mg/20mL | Injection, Powder, Lyophilized, For suspensionIntravenous | Cipla USA Inc. | 69097-398 |