What is NDC 0409-0302?

0409-0302 is the product NDC for Topotecan, Topotecan hydrochloride 1 mg/mL injection, solution, concentrate, listed with the FDA by Hospira, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Hospira, Inc., NDC labeler code 0409. 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?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Topotecan NDC 0409-0302 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0409-0302Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00409-0302Add 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
0409-0302-01	00409030201	1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0302-01) / 4 mL in 1 VIAL, SINGLE-DOSEMarketed from Feb 21, 2011

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): Topotecan
Generic name (nonproprietary): topotecan
Active ingredients: Topotecan hydrochloride — 1 mg/mL
Dosage form: Injection, Solution, Concentrate
Route: Intravenous
Labeler: Hospira, Inc.NDC labeler code 0409
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 200582
Marketing start: Feb 21, 2011
Listing expires: Dec 31, 2026
Other FDA classes: Topoisomerase Inhibitors (Mechanism)
Identifiers: Product ID 0409-0302_293334d4-88f2-4ec2-9eed-20975ff65c0aSPL ID 293334d4-88f2-4ec2-9eed-20975ff65c0aSPL set ID 1d4e1cce-c57e-4a8b-be96-f95a2778e221RxCUI 1799424UNII 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

N400409030201 followed by a unit qualifier and the quantity

Package 00409-0302-01. 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 Feb 1, 2021. This label includes a boxed warning.

Indications (excerpt from the label)

Topotecan Injection is indicated for the treatment of patients with small cell lung cancer (SCLC) with platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy. Topotecan Injection is a topoisomerase inhibitor indicated for treatment of small cell lung cancer (SCLC) platinum-sensitive disease in patients who progressed at least 60 days after initiation of first-line chemotherapy. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0409-0302

What is NDC 0409-0302?: 0409-0302 is the product NDC for Topotecan, Topotecan hydrochloride 1 mg/mL injection, solution, concentrate, listed with the FDA by Hospira, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Topotecan.
What is the active ingredient?: Topotecan hydrochloride.
Who is the labeler?: Hospira, Inc., NDC labeler code 0409. 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?: 1 other product NDC are listed under this name. See all Topotecan 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 NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Topotecan	Topotecan 1 mg/mL	InjectionIntravenous	Accord Healthcare Inc.	16729-243	16729-0243-31