Docetaxel (docetaxel anhydrous) NDC 67457-533

NDC codes

FDA NDC Directory

Product NDC (as listed)67457-533Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67457-0533Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
67457-533-16	67457053316	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 LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208859
Marketing start: Sep 5, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Microtubule Inhibition (Physiologic effect)
Identifiers: Product ID 67457-533_aa6fbb17-6b11-4cc2-9798-edf1e4befd47SPL ID aa6fbb17-6b11-4cc2-9798-edf1e4befd47SPL set ID 2fb017fd-e55e-43ef-9024-07f2d412b37bRxCUI 1093280, 1860619UNII 699121PHCAUPC 0367457533162, 0367457532080
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.

How CPT relates to drug billing

NDC on a medical claim

N467457053316 followed by a unit qualifier and the quantity

Package 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

Current FDA label (SPL), effective Sep 5, 2023. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 208859

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 208859
Product	Strength	Form · route	Labeler	Product NDC
Docetaxeldocetaxel anhydrous	Docetaxel anhydrous 10 mg/mL	Injection, SolutionIntravenous	Mylan Institutional LLC	72078-087