What is NDC 0781-3531?

0781-3531 is the product NDC for Paclitaxel, Paclitaxel 100 mg/20mL injection, powder, lyophilized, for suspension, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

Sandoz Inc, NDC labeler code 0781. 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?

30 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 0781-3531 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0781-3531Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00781-3531Add 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
0781-3531-91	00781353191	1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3531-91) / 20 mL in 1 VIAL, SINGLE-DOSEMarketed from Oct 9, 2024

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 100 mg/20mL
Dosage form: Injection, Powder, Lyophilized, For suspension
Route: Intravenous
Labeler: Sandoz IncNDC labeler code 0781
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212700
Marketing start: Oct 8, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Microtubule Inhibition (Physiologic effect)
Identifiers: Product ID 0781-3531_374cacf2-c5ef-4958-e063-6294a90a5b3cSPL ID 374cacf2-c5ef-4958-e063-6294a90a5b3cSPL set ID 15ca4829-8fee-45f9-b4bc-b31c15732cd6RxCUI 583214UNII P88XT4IS4DUPC 0307813531913
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

N400781353191 followed by a unit qualifier and the quantity

Package 00781-3531-91. 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 Jun 11, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. (1.1) Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. (1.2) Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. (1.3) 1.1 Metastatic Breast Cancer Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is indicated for the treatment of breast ca…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0781-3531

What is NDC 0781-3531?: 0781-3531 is the product NDC for Paclitaxel, Paclitaxel 100 mg/20mL injection, powder, lyophilized, for suspension, listed with the FDA by Sandoz Inc. It has 1 package NDC, 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?: Sandoz Inc, NDC labeler code 0781. 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?: 30 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	69339-229	69339-0229-50
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	69339-227	69339-0227-05
Paclitaxel	Paclitaxel 100 mg/20mL	Injection, Powder, Lyophilized, For suspensionIntravenous	Teva Pharmaceuticals, Inc.	0480-3290	00480-3290-01
Paclitaxel	Paclitaxel 6 mg/mL	Injection, SolutionIntravenous	Sagent Pharmaceuticals	25021-255	25021-0255-0525021-0255-1725021-0255-50
Paclitaxel	Paclitaxel 6 mg/mL	InjectionIntravenous	Alembic Pharmaceuticals Limited	46708-620	46708-0620-05

All 31 Paclitaxel NDCs