Topotecan NDC 16729-243

NDC codes

FDA NDC Directory

Product NDC (as listed)16729-243Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16729-0243Add 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
16729-243-31	16729024331	1 VIAL, MULTI-DOSE in 1 CARTON (16729-243-31) / 4 mL in 1 VIAL, MULTI-DOSEMarketed from Jul 8, 2020

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): Topotecan
Generic name (nonproprietary): topotecan
Active ingredients: Topotecan — 1 mg/mL
Dosage form: Injection
Route: Intravenous
Labeler: Accord Healthcare Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204406
Marketing start: Jul 8, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Topoisomerase Inhibitors (Mechanism)
Identifiers: Product ID 16729-243_46296320-1014-df71-e063-6294a90ac862SPL ID 46296320-1014-df71-e063-6294a90ac862SPL set ID 7636bc1e-77b6-46ad-9df0-c8bb1c5e503fRxCUI 637549UNII 7M7YKX2N15UPC 0316729243308
Pharmacologic class: Topoisomerase 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

N416729024331 followed by a unit qualifier and the quantity

Package 16729-0243-31. 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 Dec 17, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Topotecan Injection is indicated for the treatment of: small cell lung cancer sensitive disease after failure of first-line chemotherapy. In clinical studies submitted to support approval, sensitive disease was defined as disease responding to chemotherapy but subsequently progressing at least 60 days (in the Phase 3 study) or at least 90 days (in the Phase 2 studies) after chemotherapy [see Clinical Studies ( 14 ) ] . Topotecan Injection in combination with cisplatin is indicated for the treatment of: stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy. Topotecan is a topoisomerase inhibitor indicated…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)