What is NDC 25021-255?

25021-255 is the product NDC for Paclitaxel, Paclitaxel 6 mg/mL injection, solution, listed with the FDA by Sagent Pharmaceuticals. It has 3 package NDCs, shown above in 10- and 11-digit form.

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 Paclitaxel?

27 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Paclitaxel NDC 25021-255 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)25021-255Labeler and product segments. Claims need a package NDC.

Product NDC at billing width25021-0255Add 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
25021-255-05	2502102550525021025505	1 VIAL in 1 CARTON (25021-255-05) / 5 mL in 1 VIALMarketed from Feb 1, 2024
25021-255-17	2502102551725021025517	1 VIAL in 1 CARTON (25021-255-17) / 16.7 mL in 1 VIALMarketed from Feb 1, 2024
25021-255-50	2502102555025021025550	1 VIAL in 1 CARTON (25021-255-50) / 50 mL in 1 VIALMarketed from Feb 1, 2024

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
Generic name (nonproprietary): paclitaxel
Active ingredients: Paclitaxel — 6 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 207326
Marketing start: Feb 1, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Microtubule Inhibition (Physiologic effect)
Identifiers: Product ID 25021-255_5f3284c1-d03f-4fca-bb78-1ead3280af60SPL ID 5f3284c1-d03f-4fca-bb78-1ead3280af60SPL set ID 5721b9bf-c3c1-4b73-b96c-5fbe3147b6a5RxCUI 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

N425021025505 followed by a unit qualifier and the quantity

Package 25021-0255-05. 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 Jan 20, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND 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 estro…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 25021-255

What is NDC 25021-255?: 25021-255 is the product NDC for Paclitaxel, Paclitaxel 6 mg/mL injection, solution, listed with the FDA by Sagent Pharmaceuticals. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Paclitaxel.
What is the active ingredient?: Paclitaxel.
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 Paclitaxel?: 27 other product NDCs are listed under this name. See all Paclitaxel NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Paclitaxel NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Paclitaxel	Paclitaxel 6 mg/mL	InjectionIntravenous	BluePoint Laboratories	68001-705	68001-0705-27
Paclitaxel	Paclitaxel 100 mg/20mL	Injection, Powder, Lyophilized, For suspensionIntravenous	Mylan Institutional LLC	67457-937	67457-0937-50
Paclitaxelpaclitaxel (aibumin-bound)	Paclitaxel 100 mg/100mg	Injection, Powder, Lyophilized, For suspensionIntravenous	Ningbo Shuangcheng Pharmaceutical Co., Ltd	75007-041	—
Paclitaxel	Paclitaxel 6 mg/mL	Injection, SolutionIntravenous	Hospira, Inc.	61703-015	61703-0015-04
Paclitaxel	Paclitaxel 6 mg/mL	Injection, SolutionIntravenous	Natco Pharma USA LLC	69339-227	69339-0227-05
Paclitaxel	Paclitaxel 6 mg/mL	Injection, SolutionIntravenous	Natco Pharma USA LLC	69339-228	69339-0228-17
Paclitaxel	Paclitaxel 6 mg/mL	Injection, SolutionIntravenous	Natco Pharma USA LLC	69339-229	69339-0229-50
Paclitaxel	Paclitaxel 100 mg/20mL	Injection, Powder, Lyophilized, For suspensionIntravenous	Sandoz Inc	0781-3531	00781-3531-91
Paclitaxel	Paclitaxel 100 mg/20mL	Injection, Powder, Lyophilized, For suspensionIntravenous	Teva Pharmaceuticals, Inc.	0480-3290	00480-3290-01
Paclitaxel	Paclitaxel 6 mg/mL	InjectionIntravenous	Alembic Pharmaceuticals Limited	46708-620	46708-0620-05

All 28 Paclitaxel NDCs

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	68083-178
Paclitaxel Paclitaxelpaclitaxel	Paclitaxel 6 mg/mL	Injection, SolutionIntravenous	Gland Pharma Limited	68083-179
Paclitaxel Paclitaxelpaclitaxel	Paclitaxel 6 mg/mL	Injection, SolutionIntravenous	Gland Pharma Limited	68083-180