Prescription drug · ANDA
Paclitaxel NDC 46708-622
Paclitaxel 6 mg/mL · Injection · Intravenous · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-622-50 | 46708062250 | 1 VIAL, MULTI-DOSE in 1 CARTON (46708-622-50) / 50 mL in 1 VIAL, MULTI-DOSEMarketed from Oct 20, 2022 |
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
- Generic name (nonproprietary)
- paclitaxel
- Active ingredients
- Paclitaxel — 6 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216874
- Marketing start
- Listing expires
- Other FDA classes
- Microtubule Inhibition (Physiologic effect)
- Identifiers
- Product ID 46708-622_6d04b514-c85c-4db1-919e-21dd98172791SPL ID 6d04b514-c85c-4db1-919e-21dd98172791SPL set ID 6d04b514-c85c-4db1-919e-21dd98172791RxCUI 312199UNII 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
N446708062250followed by a unit qualifier and the quantityPackage 46708-0622-50. 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)
INDICATIONS AND USAGE Paclitaxel Injection, USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, Paclitaxel Injection, USP is indicated in combination with cisplatin. Paclitaxel Injection, USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) o…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216874
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 | Paclitaxel 6 mg/mL | InjectionIntravenous | Alembic Pharmaceuticals Inc. | 62332-621 |
| Paclitaxel | Paclitaxel 6 mg/mL | InjectionIntravenous | Alembic Pharmaceuticals Inc. | 62332-620 |
| Paclitaxel | Paclitaxel 6 mg/mL | InjectionIntravenous | Alembic Pharmaceuticals Inc. | 62332-622 |
| Paclitaxel | Paclitaxel 6 mg/mL | InjectionIntravenous | Alembic Pharmaceuticals Limited | 46708-621 |
| Paclitaxel | Paclitaxel 6 mg/mL | InjectionIntravenous | Alembic Pharmaceuticals Limited | 46708-620 |
| Paclitaxel | Paclitaxel 6 mg/mL | InjectionIntravenous | BluePoint Laboratories | 68001-705 |