Prescription drug · ANDA
Docetaxel (Docetaxel anhydrous) NDC 67457-533
Docetaxel anhydrous 10 mg/mL · Injection, Solution · Intravenous · Mylan Institutional LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67457-533-16 | 6745705331667457053316 | 1 VIAL, MULTI-DOSE in 1 CARTON (67457-533-16) / 16 mL in 1 VIAL, MULTI-DOSEMarketed from Sep 5, 2018 |
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 — 10 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Mylan Institutional LLCNDC labeler code 67457
- 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 67457-533_602500c2-99c6-46fa-aa9f-a28cf4813929SPL ID 602500c2-99c6-46fa-aa9f-a28cf4813929
- 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
N467457053316followed by a unit qualifier and the quantityPackage 67457-0533-16. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 67457-533
- What is NDC 67457-533?
- 67457-533 is the product NDC for Docetaxel (docetaxel anhydrous), Docetaxel anhydrous 10 mg/mL injection, solution, listed with the FDA by Mylan Institutional LLC. It has 1 package NDC, 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?
- Mylan Institutional LLC, NDC labeler code 67457. 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 | 72078-087 |