Hycamtin (topotecan) NDC 66758-101

NDC codes

FDA NDC Directory

Product NDC (as listed)66758-101Labeler and product segments. Claims need a package NDC.

Product NDC at billing width66758-0101Add 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
66758-101-11	66758010111	10 CAPSULE in 1 BOTTLE (66758-101-11)Marketed from Jan 6, 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): Hycamtin
Generic name (nonproprietary): topotecan
Active ingredients: Topotecan hydrochloride — .25 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Sandoz Inc
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020981
Marketing start: Jul 7, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Topoisomerase Inhibitors (Mechanism)
Identifiers: Product ID 66758-101_b23b46f5-c276-47f5-8bbd-940680b3f579SPL ID b23b46f5-c276-47f5-8bbd-940680b3f579SPL set ID b23b46f5-c276-47f5-8bbd-940680b3f579RxCUI 747193, 747195, 748738, 748740UNII 956S425ZCY
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N466758010111 followed by a unit qualifier and the quantity

Package 66758-0101-11. 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 18, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

HYCAMTIN ® capsules are indicated for the treatment of relapsed small cell lung cancer (SCLC) in patients with a prior complete or partial response and who are at least 45 days from the end of first-line chemotherapy. HYCAMTIN capsules is a topoisomerase inhibitor indicated for treatment of patients with relapsed small cell lung cancer (SCLC). ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 020981

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

FDA NDC Directory listings under NDA 020981
Product	Strength	Form · route	Labeler	Product NDC
Hycamtintopotecan	Topotecan hydrochloride 1 mg/1	CapsuleOral	Sandoz Inc	66758-102