What is NDC 10511-3001?

10511-3001 is the product NDC for Cysview (hexaminolevulinate hydrochloride) kit, listed with the FDA by Photocure Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Cysview (Hexaminolevulinate hydrochloride).

Photocure Inc., NDC labeler code 10511. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Cysview?

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.

Cysview NDC 10511-3001 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)10511-3001Labeler and product segments. Claims need a package NDC.

Product NDC at billing width10511-3001Add 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
10511-3001-2	10511300102	1 KIT in 1 CARTON (10511-3001-2) * 50 mL in 1 SYRINGE, PLASTIC * 50 mL in 1 VIAL, GLASSMarketed from May 1, 2018

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): Cysview
Generic name (nonproprietary): hexaminolevulinate hydrochloride
Dosage form: Kit
Labeler: Photocure Inc.NDC labeler code 10511
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022555
Marketing start: May 1, 2018
Listing expires: Dec 31, 2027
Identifiers: Product ID 10511-3001_49603d9a-adbb-4f38-a35f-d4e969c92a79SPL ID 49603d9a-adbb-4f38-a35f-d4e969c92a79SPL set ID 5aeed40d-6841-4adf-8940-f51d439fdfa3UPC 0310511300125

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

N410511300102 followed by a unit qualifier and the quantity

Package 10511-3001-02. 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 3, 2026.

Indications (excerpt from the label)

CYSVIEW is indicated for the cystoscopic detection of carcinoma of the bladder, including carcinoma in situ (CIS), in adult patients: With suspected or known lesion(s) based on a prior cystoscopy Undergoing surveillance cystoscopy for bladder cancer Limitations of Use CYSVIEW is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer [see Warnings and Precautions (5.2) ] . CYSVIEW is an optical imaging agent indicated for the cystoscopic detection of carcinoma of the bladder, including carcinoma in situ (CIS), in adult patients: With suspected or known lesion(s) on the basis of a prior cystoscopy Undergoing surveillance cystoscopy for bladder…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 10511-3001

What is NDC 10511-3001?: 10511-3001 is the product NDC for Cysview (hexaminolevulinate hydrochloride) kit, listed with the FDA by Photocure Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Cysview (Hexaminolevulinate hydrochloride).
Who is the labeler?: Photocure Inc., NDC labeler code 10511. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cysview?: 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.

Cysview (Hexaminolevulinate hydrochloride) NDC 10511-3001