Prescription drug · ANDA
Docetaxel (Docetaxel anhydrous) NDC 72078-087
Docetaxel anhydrous 10 mg/mL · Injection, Solution · Intravenous · Mylan Institutional LLC
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Docetaxel
- Generic name (nonproprietary)
- docetaxel anhydrous
- Active ingredients
- Docetaxel anhydrous — 10 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Mylan Institutional LLCNDC labeler code 72078
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208859
- Marketing start
- Listing expires
- Other FDA classes
- Microtubule Inhibition (Physiologic effect)
- Identifiers
- Product ID 72078-087_3eb46e06-aabe-42b6-ac06-057bca6e0d38SPL ID 3eb46e06-aabe-42b6-ac06-057bca6e0d38SPL set ID 2992d633-08fa-44f3-b14d-41700f24686bRxCUI 1093280, 1860619UNII 699121PHCA
- 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.
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, includi…
Excerpt only. Read the full label for complete information.
About NDC 72078-087
- What is NDC 72078-087?
- 72078-087 is the product NDC for Docetaxel (docetaxel anhydrous), Docetaxel anhydrous 10 mg/mL injection, solution, listed with the FDA by Mylan Institutional LLC.
- What drug is associated with this NDC?
- Docetaxel (Docetaxel anhydrous).
- What is the active ingredient?
- Docetaxel anhydrous.
- Who is the labeler?
- Mylan Institutional LLC, NDC labeler code 72078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Docetaxel?
- 61 other product NDCs are listed under this name. See all Docetaxel NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Docetaxel products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Docetaxel | Docetaxel anhydrous 10 mg/mL | InjectionIntravenous | Baxter Healthcare Corporation | 43066-044 | 43066-0044-02 |
| Docetaxel | Docetaxel anhydrous 10 mg/mL | InjectionIntravenous | Baxter Healthcare Corporation | 43066-046 | 43066-0046-08 |
| Docetaxel | Docetaxel anhydrous 10 mg/mL | InjectionIntravenous | Baxter Healthcare Corporation | 43066-048 | 43066-0048-16 |
| Docetaxel | Docetaxel 20 mg/mL | Injection, Solution, ConcentrateIntravenous | Meitheal Pharmaceuticals Inc. | 71288-133 | 71288-0133-01 |
| Docetaxel | Docetaxel 20 mg/mL | Injection, Solution, ConcentrateIntravenous | Meitheal Pharmaceuticals Inc. | 71288-152 | 71288-0152-04 |
| Docetaxel | Docetaxel 20 mg/mL | InjectionIntravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-903 | 23155-0903-31 |
| Docetaxel | Docetaxel 80 mg/4mL | InjectionIntravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-904 | 23155-0904-31 |
| Docetaxel | Docetaxel 160 mg/8mL | InjectionIntravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-905 | 23155-0905-31 |
| Docetaxeldocetaxel anhydrous | Docetaxel anhydrous 10 mg/mL | InjectionIntravenous | Sagent Pharmaceuticals | 25021-254 | 25021-0254-0825021-0254-16 |
| Docetaxel | Docetaxel anhydrous 10 mg/mL | InjectionIntravenous | Alembic Pharmaceuticals Limited | 46708-678 | 46708-0678-0246708-0678-0846708-0678-16 |
Other NDCs under ANDA 208859
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 10 mg/mL | Injection, SolutionIntravenous | Mylan Institutional LLC | 67457-533 |