NDC codes

FDA NDC Directory
Product NDC (as listed)0019-0862Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00019-0862Add 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 NDC11-digit (billing)PackageCopy
0019-0862-500001908625012 BOTTLE, GLASS in 1 BOX (0019-0862-50) / 250 mL in 1 BOTTLE, GLASSMarketed from Oct 8, 2010

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)
Cysto-Conray II
Generic name (nonproprietary)
iothalamate meglumine
Active ingredients
Iothalamate meglumine — 172 mg/mL
Dosage form
Injection
Route
Ureteral
Labeler
Liebel-Flarsheim Company LLCNDC labeler code 0019
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 017057
Marketing start
Listing expires
Other FDA classes
X-Ray Contrast Activity (Mechanism)
Identifiers
Product ID 0019-0862_ff628e06-2cb5-4714-a741-1dec04bd5602SPL ID ff628e06-2cb5-4714-a741-1dec04bd5602SPL set ID 8841ab4d-674d-4beb-88a5-13e35f6005ccUNII XUW72GOP7WUPC 0300190862502
Pharmacologic class
Radiographic Contrast Agent

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

N400019086250 followed by a unit qualifier and the quantity

Package 00019-0862-50. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Cysto-Conray II is indicated for use in retrograde cystography and cystourethrography.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0019-0862

What is NDC 0019-0862?
0019-0862 is the product NDC for Cysto-Conray II (iothalamate meglumine), Iothalamate meglumine 172 mg/mL injection, listed with the FDA by Liebel-Flarsheim Company LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Cysto-Conray II (Iothalamate meglumine).
What is the active ingredient?
Iothalamate meglumine.
Who is the labeler?
Liebel-Flarsheim Company LLC, NDC labeler code 0019. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cysto-Conray II?
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.

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