What is NDC 69097-398?

69097-398 is the product NDC for Paclitaxel protein-bound particles, Paclitaxel 100 mg/20mL injection, powder, lyophilized, for suspension, listed with the FDA by Cipla USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Cipla USA Inc., NDC labeler code 69097. 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 protein-bound particles?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Paclitaxel protein-bound particles NDC 69097-398

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-398Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0398Add 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
69097-398-78	6909703987869097039878	1 VIAL, SINGLE-DOSE in 1 CARTON (69097-398-78) / 20 mL in 1 VIAL, SINGLE-DOSEMarketed from Apr 15, 2025

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 protein-bound particles
Generic name (nonproprietary): paclitaxel protein-bound particles
Active ingredients: Paclitaxel — 100 mg/20mL
Dosage form: Injection, Powder, Lyophilized, For suspension
Route: Intravenous
Labeler: Cipla USA Inc.NDC labeler code 69097
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209657
Marketing start: Apr 15, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Microtubule Inhibition (Physiologic effect)
Identifiers: Product ID 69097-398_7dcacda6-4a5c-4840-8f8d-cbf7b30f3415SPL ID 7dcacda6-4a5c-4840-8f8d-cbf7b30f3415SPL set ID 15eba86c-d9de-42e6-bc95-70ba4c015e72RxCUI 583214UNII P88XT4IS4DUPC 0369097398781
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

N469097039878 followed by a unit qualifier and the quantity

Package 69097-0398-78. 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 Apr 2, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Paclitaxel is a microtubule inhibitor indicated for the treatment of: 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 injec…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69097-398

What is NDC 69097-398?: 69097-398 is the product NDC for Paclitaxel protein-bound particles, Paclitaxel 100 mg/20mL injection, powder, lyophilized, for suspension, listed with the FDA by Cipla USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Paclitaxel protein-bound particles.
What is the active ingredient?: Paclitaxel.
Who is the labeler?: Cipla USA Inc., NDC labeler code 69097. 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 protein-bound particles?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 209657

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

FDA NDC Directory listings under ANDA 209657
Product	Strength	Form · route	Labeler	Product NDC
Paclitaxel 100mg per vialpaclitaxel protein-bound particles	Paclitaxel 100 mg/20mL	Injection, Powder, Lyophilized, For suspensionIntravenous	EXELAN PHARMACEUTICALS INC.	76282-768