Prescription drug · ANDA
Paclitaxel protein-bound particles for injectable suspension (albumin-bound) (Paclitaxel) NDC 71288-183
Paclitaxel 100 mg/20mL · Injection, Powder, Lyophilized, For suspension · Intravenous · Meitheal Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71288-183-50 | 7128801835071288018350 | 1 VIAL, SINGLE-USE in 1 CARTON (71288-183-50) / 20 mL in 1 VIAL, SINGLE-USEMarketed from May 15, 2025 |
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 protein-bound particles for injectable suspension (albumin-bound)
- Generic name (nonproprietary)
- paclitaxel
- Active ingredients
- Paclitaxel — 100 mg/20mL
- Dosage form
- Injection, Powder, Lyophilized, For suspension
- Route
- Intravenous
- Labeler
- Meitheal Pharmaceuticals Inc.NDC labeler code 71288
- 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 71288-183_ab2be690-a801-46c1-a254-213c3893fc24SPL ID ab2be690-a801-46c1-a254-213c3893fc24SPL set ID 31e893aa-8d9e-4576-8614-eb2fe772bde4RxCUI 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
N471288018350followed by a unit qualifier and the quantityPackage 71288-0183-50. 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)
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…
Excerpt only. Read the full label for complete information.
About NDC 71288-183
- What is NDC 71288-183?
- 71288-183 is the product NDC for Paclitaxel protein-bound particles for injectable suspension (albumin-bound), Paclitaxel 100 mg/20mL injection, powder, lyophilized, for suspension, listed with the FDA by Meitheal Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Paclitaxel protein-bound particles for injectable suspension (albumin-bound) (Paclitaxel).
- What is the active ingredient?
- Paclitaxel.
- Who is the labeler?
- Meitheal Pharmaceuticals Inc., NDC labeler code 71288. 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 protein-bound particles for injectable suspension (albumin-bound)?
- 2 other product NDCs are listed under this name. See all Paclitaxel protein-bound particles for injectable suspension (albumin-bound) NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 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 protein-bound particles for injectable suspension (albumin-bound)paclitaxel | Paclitaxel 100 mg/20mL | Injection, Powder, Lyophilized, For suspensionIntravenous | NorthStar Rx LLC | 72603-408 | 72603-0408-01 |
| Paclitaxel protein-bound particles for injectable suspension (albumin-bound)paclitaxel | Paclitaxel 100 mg/20mL | Injection, Powder, Lyophilized, For suspensionIntravenous | BluePoint Laboratories | 68001-651 | 68001-0651-37 |
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 |
|---|---|---|---|---|
| Paclitaxelpaclitaxel (aibumin-bound) | Paclitaxel 100 mg/100mg | Injection, Powder, Lyophilized, For suspensionIntravenous | Ningbo Shuangcheng Pharmaceutical Co., Ltd | 75007-041 |
| 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 | NorthStar Rx LLC | 72603-408 |