Prescription drug · ANDA
Docetaxel NDC 43598-610
Docetaxel 80 mg/4mL · Injection, Solution · Intravenous · Dr. Reddy's Laboratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-610-40 | 43598061040 | 4 mL in 1 VIAL, GLASS (43598-610-40)Marketed from Aug 22, 2017 |
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)
- Docetaxel
- Generic name (nonproprietary)
- docetaxel
- Active ingredients
- Docetaxel — 80 mg/4mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204193
- Marketing start
- Listing expires
- Other FDA classes
- Microtubule Inhibition (Physiologic effect)
- Identifiers
- Product ID 43598-610_948f7c4c-6a40-d240-3eb3-d9ae6e371429SPL ID 948f7c4c-6a40-d240-3eb3-d9ae6e371429SPL set ID be3df07d-ea56-453a-25ad-c3cedc22712aRxCUI 1860480, 1860485UNII 15H5577CQD
- 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
N443598061040followed by a unit qualifier and the quantityPackage 43598-0610-40. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 204193
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 |
|---|---|---|---|---|
| Docetaxel | Docetaxel 20 mg/mL | Injection, SolutionIntravenous | Dr. Reddy's Laboratories Inc. | 43598-258 |
| Docetaxel | Docetaxel 80 mg/4mL | Injection, SolutionIntravenous | Dr. Reddy's Laboratories Inc. | 43598-259 |
| Docetaxel | Docetaxel 160 mg/8mL | Injection, SolutionIntravenous | Dr. Reddy's Laboratories Inc. | 43598-389 |
| Docetaxel | Docetaxel 20 mg/mL | Injection, SolutionIntravenous | Dr. Reddy's Laboratories Inc. | 43598-611 |