Prescription drug · NDA
Docetaxel NDC 45963-734
Docetaxel 20 mg/mL · Injection, Solution, Concentrate · Intravenous · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45963-734-54 | 45963073454 | 1 VIAL, GLASS in 1 CARTON (45963-734-54) / 1 mL in 1 VIAL, GLASSMarketed from Sep 1, 2014 |
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 — 20 mg/mL
- Dosage form
- Injection, Solution, Concentrate
- Route
- Intravenous
- Labeler
- Actavis Pharma, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 203551
- Marketing start
- Listing expires
- Other FDA classes
- Microtubule Inhibition (Physiologic effect)
- Identifiers
- Product ID 45963-734_0bc8d3b7-f15e-4dbf-b51f-8baaa93b0e61SPL ID 0bc8d3b7-f15e-4dbf-b51f-8baaa93b0e61SPL set ID 2c806400-5fdc-4398-8475-37f700b3191fRxCUI 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
N445963073454followed by a unit qualifier and the quantityPackage 45963-0734-54. 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)
Docetaxel Injection is a microtubule inhibitor indicated for: Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC ( 1.1 ) Non-Small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC ( 1.2 ) Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer ( 1.3 ) Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the g…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 203551
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, Solution, ConcentrateIntravenous | Actavis Pharma, Inc. | 45963-765 |