Prescription drug · ANDA
Docetaxel (Docetaxel anhydrous) NDC 25021-245
Docetaxel anhydrous 20 mg/mL · Injection, Solution · Intravenous · Sagent Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25021-245-01 | 2502102450125021024501 | 1 VIAL in 1 CARTON (25021-245-01) / 1 mL in 1 VIALMarketed from Sep 15, 2017 | |
| 25021-245-04 | 2502102450425021024504 | 1 VIAL in 1 CARTON (25021-245-04) / 4 mL in 1 VIALMarketed from Sep 15, 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 anhydrous
- Active ingredients
- Docetaxel anhydrous — 20 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Sagent PharmaceuticalsNDC labeler code 25021
- 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 25021-245_3897fe0d-2b9f-4be0-9076-9ccd693d4c86SPL ID 3897fe0d-2b9f-4be0-9076-9ccd693d4c86SPL set ID 30077f79-341f-4618-9ec5-23b17b212faeRxCUI 1860480, 1860485UNII 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.
- NDC on a medical claim
N425021024501followed by a unit qualifier and the quantityPackage 25021-0245-01. 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 t…
Excerpt only. Read the full label for complete information.
About NDC 25021-245
- What is NDC 25021-245?
- 25021-245 is the product NDC for Docetaxel (docetaxel anhydrous), Docetaxel anhydrous 20 mg/mL injection, solution, listed with the FDA by Sagent Pharmaceuticals. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Docetaxel (Docetaxel Anhydrous).
- What is the active ingredient?
- Docetaxel anhydrous.
- Who is the labeler?
- Sagent Pharmaceuticals, NDC labeler code 25021. 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 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 |
|---|---|---|---|---|
| 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 |
| Docetaxel | Docetaxel 160 mg/8mL | Injection, Solution, ConcentrateIntravenous | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | 57884-3043 |