Prescription drug · NDA
Optiray 320 (Ioversol) NDC 0019-1323
Ioversol 678 mg/mL · Injection · Intra-arterial, Intravenous · Liebel-Flarsheim Company LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0019-1323-65 | 00019132365 | 6 BOTTLE, GLASS in 1 CARTON (0019-1323-65) / 500 mL in 1 BOTTLE, GLASSMarketed from Nov 18, 2020 |
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)
- Optiray 320Suffix: 320
- Generic name (nonproprietary)
- ioversol
- Active ingredients
- Ioversol — 678 mg/mL
- Dosage form
- Injection
- Route
- Intra-arterial, Intravenous
- Labeler
- Liebel-Flarsheim Company LLCNDC labeler code 0019
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020923
- Marketing start
- Listing expires
- Other FDA classes
- X-Ray Contrast Activity (Mechanism)
- Identifiers
- Product ID 0019-1323_471b778f-d9cc-ff10-e063-6394a90a27c9SPL ID 471b778f-d9cc-ff10-e063-6394a90a27c9SPL set ID cd718d1c-f813-4114-a50d-c744ff7eb1bfUNII N3RIB7X24KUPC 0300191332653, 0300191323651, 0300191333650
- 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.
- 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.
- NDC on a medical claim
N400019132365followed by a unit qualifier and the quantityPackage 00019-1323-65. 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)
OPTIRAY is indicated for: OPTIRAY is a radiographic contrast agent indicated for the following: Intra-arterial Procedures ( 1.1 ) Adults: Cerebral Arteriography (320 mg iodine/mL) Peripheral Arteriography (320, 350 mg iodine/mL ) Visceral and Renal Arteriography, Aortography (320 mg iodine/mL) Coronary Arteriography and Left Ventriculography (320, 350 mg iodine/mL) Pediatric Patients: Angiocardiography (320, 350 mg iodine/mL) Intravenous Procedures ( 1.2 ) Adults: Computed tomography (CT) Imaging of Head and Body (320, 350 mg iodine/mL) Venography (320, 350 mg iodine/mL) Intravenous Excretory Urography (320, 350 mg iodine/mL) Intravenous Digital Subtraction Angiography (350 mg iodine/mL) Ped…
Excerpt only. Read the full label for complete information.
About NDC 0019-1323
- What is NDC 0019-1323?
- 0019-1323 is the product NDC for Optiray 320 (ioversol), Ioversol 678 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?
- Optiray 320 (Ioversol).
- What is the active ingredient?
- Ioversol.
- 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 Optiray 320?
- 2 other product NDCs are listed under this name. See all Optiray 320 NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under NDA 020923
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Optiray 350ioversol | Ioversol 741 mg/mL | InjectionIntra-arterial, Intravenous | Liebel-Flarsheim Company LLC | 0019-1333 |
| Optiray 350ioversol | Ioversol 741 mg/mL | InjectionIntra-arterial, Intravenous | Liebel-Flarsheim Company LLC | 0019-1333 |