Prescription drug · NDA
Cysto-Conray II (Iothalamate meglumine) NDC 0019-0862
Iothalamate meglumine 172 mg/mL · Injection · Ureteral · Liebel-Flarsheim Company LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0019-0862-50 | 00019086250 | 12 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
N400019086250followed by a unit qualifier and the quantityPackage 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.
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.