Prescription drug · ANDA
Paclitaxel (Paclitaxel (aibumin-bound)) NDC 75007-041
Paclitaxel 100 mg/100mg · Injection, Powder, Lyophilized, For suspension · Intravenous · Ningbo Shuangcheng Pharmaceutical Co., Ltd
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Paclitaxel
- Generic name (nonproprietary)
- paclitaxel (aibumin-bound)
- Active ingredients
- Paclitaxel — 100 mg/100mg
- Dosage form
- Injection, Powder, Lyophilized, For suspension
- Route
- Intravenous
- Labeler
- Ningbo Shuangcheng Pharmaceutical Co., LtdNDC labeler code 75007
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216355
- Marketing start
- Listing expires
- Other FDA classes
- Microtubule Inhibition (Physiologic effect)
- Identifiers
- Product ID 75007-041_c455b438-d057-4568-a66a-68775a878fdcSPL ID c455b438-d057-4568-a66a-68775a878fdcSPL set ID 4df3fda6-0b29-420e-ab91-81441ce914edRxCUI 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.
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 75007-041
- What is NDC 75007-041?
- 75007-041 is the product NDC for Paclitaxel (paclitaxel (aibumin-bound)), Paclitaxel 100 mg/100mg injection, powder, lyophilized, for suspension, listed with the FDA by Ningbo Shuangcheng Pharmaceutical Co., Ltd.
- What drug is associated with this NDC?
- Paclitaxel (Paclitaxel (aibumin-bound)).
- What is the active ingredient?
- Paclitaxel.
- Who is the labeler?
- Ningbo Shuangcheng Pharmaceutical Co., Ltd, NDC labeler code 75007. 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?
- 27 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 |
| 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 | 69339-227 | 69339-0227-05 |
| 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 | 69339-229 | 69339-0229-50 |
| Paclitaxel | Paclitaxel 100 mg/20mL | Injection, Powder, Lyophilized, For suspensionIntravenous | Sandoz Inc | 0781-3531 | 00781-3531-91 |
| Paclitaxel | Paclitaxel 100 mg/20mL | Injection, Powder, Lyophilized, For suspensionIntravenous | Teva Pharmaceuticals, Inc. | 0480-3290 | 00480-3290-01 |
| 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 Limited | 46708-620 | 46708-0620-05 |
Other NDCs under ANDA 216355
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 for injectable suspension (albumin-bound)paclitaxel | Paclitaxel 100 mg/20mL | Injection, Powder, Lyophilized, For suspensionIntravenous | BluePoint Laboratories | 68001-651 |
| Paclitaxel protein-bound particles for injectable suspension (albumin-bound)paclitaxel | Paclitaxel 100 mg/20mL | Injection, Powder, Lyophilized, For suspensionIntravenous | Meitheal Pharmaceuticals Inc. | 71288-183 |
| Paclitaxel protein-bound particles for injectable suspension (albumin-bound)paclitaxel | Paclitaxel 100 mg/20mL | Injection, Powder, Lyophilized, For suspensionIntravenous | NorthStar Rx LLC | 72603-408 |