Prescription drug · ANDA
Docetaxel NDC 57884-3043
Docetaxel 160 mg/8mL · Injection, Solution, Concentrate · Intravenous · Jiangsu Hengrui Pharmaceuticals Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57884-3043-1 | 57884304301 | 1 VIAL, GLASS in 1 CARTON (57884-3043-1) / 8 mL in 1 VIAL, GLASSMarketed from Aug 9, 2017 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 160 mg/8mL
- Dosage form
- Injection, Solution, Concentrate
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207252
- Marketing start
- Listing expires
- Other FDA classes
- Microtubule Inhibition (Physiologic effect)
- Identifiers
- Product ID 57884-3043_05e0099c-4a6e-4ca4-e063-6394a90ae073SPL ID 05e0099c-4a6e-4ca4-e063-6394a90ae073SPL set ID e488100d-6728-4f44-9282-f63a805b8e13RxCUI 1860480, 1860485, 1861411UNII 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
N457884304301followed by a unit qualifier and the quantityPackage 57884-3043-01. 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 gast…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207252
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 |
|---|---|---|---|---|
| Docetaxeldocetaxel anhydrous | Docetaxel anhydrous 20 mg/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-245 |
| Docetaxel | Docetaxel 20 mg/mL | Injection, Solution, ConcentrateIntravenous | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | 57884-3041 |
| Docetaxel | Docetaxel 80 mg/4mL | Injection, Solution, ConcentrateIntravenous | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | 57884-3042 |