What is NDC 45963-615?

45963-615 is the product NDC for Topotecan hydrochloride, Topotecan hydrochloride 4 mg/4mL injection, powder, lyophilized, for solution, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Actavis Pharma, Inc., NDC labeler code 45963. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Topotecan hydrochloride?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Topotecan hydrochloride NDC 45963-615 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)45963-615Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45963-0615Add 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
45963-615-56	45963061556	1 VIAL in 1 CARTON (45963-615-56) / 4 mL in 1 VIALMarketed from Jan 5, 2015

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 hydrochloride
Generic name (nonproprietary): topotecan hydrochloride
Active ingredients: Topotecan hydrochloride — 4 mg/4mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Actavis Pharma, Inc.NDC labeler code 45963
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090620
Marketing start: Jan 5, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Topoisomerase Inhibitors (Mechanism)
Identifiers: Product ID 45963-615_0edbf531-9ae9-4f9d-a606-f8f56768ce9dSPL ID 0edbf531-9ae9-4f9d-a606-f8f56768ce9dSPL set ID 996430c0-ee26-4ed9-82b8-a8b645becba6RxCUI 1799416UNII 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 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

N445963061556 followed by a unit qualifier and the quantity

Package 45963-0615-56. 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 Aug 31, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

Topotecan hydrochloride for injection is a topoisomerase inhibitor indicated for treatment of: Patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy, as a single agent ( 1.1 ) Patients with small cell lung cancer (SCLC) platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy, as a single agent ( 1.2 ) Patients with Stage IV-B, recurrent, or persistent cervical cancer which is not amenable to curative treatment, in combination with cisplatin ( 1.3 ) 1.1 Ovarian Cancer Topotecan hydrochloride for injection, as a single agent, is indicated for the treatment of patients with metastatic ovari…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 45963-615

What is NDC 45963-615?: 45963-615 is the product NDC for Topotecan hydrochloride, Topotecan hydrochloride 4 mg/4mL injection, powder, lyophilized, for solution, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Topotecan hydrochloride.
What is the active ingredient?: Topotecan hydrochloride.
Who is the labeler?: Actavis Pharma, Inc., NDC labeler code 45963. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Topotecan hydrochloride?: 2 other product NDCs are listed under this name. See all Topotecan hydrochloride 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 Topotecan hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
topotecan hydrochloride	Topotecan hydrochloride 4 mg/4mL	Injection, Powder, Lyophilized, For solutionIntravenous	Accord Healthcare, Inc.	16729-151	16729-0151-31
Topotecan Hydrochloride	Topotecan hydrochloride 4 mg/4mL	Injection, Powder, Lyophilized, For solutionIntravenous	Fresenius Kabi USA, LLC	63323-762	63323-0762-10