Prescription drug · NDA
Paclitaxel NDC 0480-3290
Paclitaxel 100 mg/20mL · Injection, Powder, Lyophilized, For suspension · Intravenous · Teva Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0480-3290-01 | 00480329001 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0480-3290-01) / 20 mL in 1 VIAL, SINGLE-DOSEMarketed from Jul 2, 2024 |
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)
- Paclitaxel
- Generic name (nonproprietary)
- paclitaxel
- Active ingredients
- Paclitaxel — 100 mg/20mL
- Dosage form
- Injection, Powder, Lyophilized, For suspension
- Route
- Intravenous
- Labeler
- Teva Pharmaceuticals, Inc.NDC labeler code 0480
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 216338
- Marketing start
- Listing expires
- Other FDA classes
- Microtubule Inhibition (Physiologic effect)
- Identifiers
- Product ID 0480-3290_2fbc2699-cf99-497c-94b9-8a2c534c061fSPL ID 2fbc2699-cf99-497c-94b9-8a2c534c061fSPL set ID 15dd51ed-29e8-468b-b6d1-21b1f84d6f2eRxCUI 583214UNII P88XT4IS4D
- 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
N400480329001followed by a unit qualifier and the quantityPackage 00480-3290-01. 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)
Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) 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 Met…
Excerpt only. Read the full label for complete information.
About NDC 0480-3290
- What is NDC 0480-3290?
- 0480-3290 is the product NDC for Paclitaxel, Paclitaxel 100 mg/20mL injection, powder, lyophilized, for suspension, listed with the FDA by Teva Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Paclitaxel.
- What is the active ingredient?
- Paclitaxel.
- Who is the labeler?
- Teva Pharmaceuticals, Inc., NDC labeler code 0480. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Paclitaxel?
- 30 other product NDCs are listed under this name. See all Paclitaxel NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Paclitaxel products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Paclitaxel | Paclitaxel 6 mg/mL | InjectionIntravenous | BluePoint Laboratories | 68001-705 | 68001-0705-27 |
| Paclitaxel | Paclitaxel 100 mg/20mL | Injection, Powder, Lyophilized, For suspensionIntravenous | Mylan Institutional LLC | 67457-937 | 67457-0937-50 |
| Paclitaxelpaclitaxel (aibumin-bound) | Paclitaxel 100 mg/100mg | Injection, Powder, Lyophilized, For suspensionIntravenous | Ningbo Shuangcheng Pharmaceutical Co., Ltd | 75007-041 | — |
| Paclitaxel | Paclitaxel 6 mg/mL | Injection, SolutionIntravenous | Hospira, Inc. | 61703-015 | 61703-0015-04 |
| Paclitaxel | Paclitaxel 6 mg/mL | Injection, SolutionIntravenous | Natco Pharma USA LLC | 69339-228 | 69339-0228-17 |
| Paclitaxel | Paclitaxel 6 mg/mL | Injection, SolutionIntravenous | Natco Pharma USA LLC | 69339-227 | 69339-0227-05 |
| Paclitaxel | Paclitaxel 6 mg/mL | Injection, SolutionIntravenous | Natco Pharma USA LLC | 69339-229 | 69339-0229-50 |
| Paclitaxel | Paclitaxel 100 mg/20mL | Injection, Powder, Lyophilized, For suspensionIntravenous | Sandoz Inc | 0781-3531 | 00781-3531-91 |
| Paclitaxel | Paclitaxel 6 mg/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-255 | 25021-0255-0525021-0255-1725021-0255-50 |
| Paclitaxel | Paclitaxel 6 mg/mL | InjectionIntravenous | Alembic Pharmaceuticals Inc. | 62332-622 | 62332-0622-50 |