What is NDC 24201-101?

24201-101 is the product NDC for Valrubicin Intravesical Solution, Valrubicin 40 mg/mL solution, concentrate, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Hikma Pharmaceuticals USA Inc., NDC labeler code 24201. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Valrubicin Intravesical Solution?

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.

Valrubicin Intravesical Solution NDC 24201-101

NDC codes

FDA NDC Directory

Product NDC (as listed)24201-101Labeler and product segments. Claims need a package NDC.

Product NDC at billing width24201-0101Add 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
24201-101-04	24201010104	4 VIAL in 1 CARTON (24201-101-04) / 5 mL in 1 VIALMarketed from Apr 23, 2019

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): Valrubicin Intravesical Solution
Generic name (nonproprietary): valrubicin intravesical solution
Active ingredients: Valrubicin — 40 mg/mL
Dosage form: Solution, Concentrate
Route: Intravesical
Labeler: Hikma Pharmaceuticals USA Inc.NDC labeler code 24201
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206430
Marketing start: Apr 23, 2019
Listing expires: Dec 31, 2026
Identifiers: Product ID 24201-101_f2385edd-45ba-4ce8-97a0-ac301d067536SPL ID f2385edd-45ba-4ce8-97a0-ac301d067536SPL set ID 8739ae02-e4c5-0fa2-e053-2a91aa0a1b74RxCUI 313567UNII 2C6NUM6878

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.

NDC on a medical claim

N424201010104 followed by a unit qualifier and the quantity

Package 24201-0101-04. 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 Jun 30, 2022.

Indications (excerpt from the label)

Valrubicin intravesical solution is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. • Valrubicin intravesical solution is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 24201-101

What is NDC 24201-101?: 24201-101 is the product NDC for Valrubicin Intravesical Solution, Valrubicin 40 mg/mL solution, concentrate, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Valrubicin Intravesical Solution.
What is the active ingredient?: Valrubicin.
Who is the labeler?: Hikma Pharmaceuticals USA Inc., NDC labeler code 24201. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Valrubicin Intravesical Solution?: 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.