Paclitaxel Paclitaxel (paclitaxel) NDC 68083-180

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-180Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0180Add 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
68083-180-01	68083018001	1 VIAL, MULTI-DOSE in 1 CARTON (68083-180-01) / 50 mL in 1 VIAL, MULTI-DOSEMarketed from Sep 30, 2016

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): Paclitaxel PaclitaxelSuffix: PACLITAXEL
Generic name (nonproprietary): paclitaxel
Active ingredients: Paclitaxel — 6 mg/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Gland Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207326
Marketing start: Sep 30, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Microtubule Inhibition (Physiologic effect)
Identifiers: Product ID 68083-180_aeff20f1-c4e7-46c6-a6cb-f0aab334571bSPL ID aeff20f1-c4e7-46c6-a6cb-f0aab334571bSPL set ID fec9ddee-53a9-4a61-ad0a-be6b604de084RxCUI 312199UNII P88XT4IS4D
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

N468083018001 followed by a unit qualifier and the quantity

Package 68083-0180-01. 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 Sep 1, 2016. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS & USAGE Paclitaxel Injection, USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, paclitaxel is indicated in combination with cisplatin. Paclitaxel is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estroge…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207326

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

FDA NDC Directory listings under ANDA 207326
Product	Strength	Form · route	Labeler	Product NDC
Paclitaxel Paclitaxelpaclitaxel	Paclitaxel 6 mg/mL	Injection, SolutionIntravenous	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-882
Paclitaxel Paclitaxelpaclitaxel	Paclitaxel 6 mg/mL	Injection, SolutionIntravenous	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-883
Paclitaxel Paclitaxelpaclitaxel	Paclitaxel 6 mg/mL	Injection, SolutionIntravenous	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-884
Paclitaxel Paclitaxelpaclitaxel	Paclitaxel 6 mg/mL	Injection, SolutionIntravenous	Gland Pharma Limited	68083-179
Paclitaxel	Paclitaxel 6 mg/mL	Injection, SolutionIntravenous	Sagent Pharmaceuticals	25021-255
Paclitaxel Paclitaxelpaclitaxel	Paclitaxel 6 mg/mL	Injection, SolutionIntravenous	Gland Pharma Limited	68083-178