Prescription drug · NDA
Optiray 300 (ioversol) NDC 0019-1332
Ioversol 636 mg/mL · Injection · Intra-arterial, Intravenous · Liebel-Flarsheim Company LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0019-1332-00 | 00019133200 | 20 SYRINGE, PLASTIC in 1 CARTON (0019-1332-00) / 100 mL in 1 SYRINGE, PLASTICMarketed from Mar 4, 2012 | |
| 0019-1332-06 | 00019133206 | 25 BOTTLE, GLASS in 1 CARTON (0019-1332-06) / 50 mL in 1 BOTTLE, GLASSMarketed from Mar 4, 2012 | |
| 0019-1332-11 | 00019133211 | 12 BOTTLE, GLASS in 1 CARTON (0019-1332-11) / 100 mL in 1 BOTTLE, GLASSMarketed from Mar 4, 2012 | |
| 0019-1332-16 | 00019133216 | 12 BOTTLE, GLASS in 1 CARTON (0019-1332-16) / 150 mL in 1 BOTTLE, GLASSMarketed from Mar 4, 2012 | |
| 0019-1332-21 | 00019133221 | 12 BOTTLE, GLASS in 1 CARTON (0019-1332-21) / 200 mL in 1 BOTTLE, GLASSMarketed from Mar 4, 2012 | |
| 0019-1332-75 | 00019133275 | 20 SYRINGE, PLASTIC in 1 CARTON (0019-1332-75) / 50 mL in 1 SYRINGE, PLASTICMarketed from Mar 4, 2012 | |
| 0019-1332-78 | 00019133278 | 20 SYRINGE, PLASTIC in 1 CARTON (0019-1332-78) / 50 mL in 1 SYRINGE, PLASTICMarketed from Mar 4, 2012 | |
| 0019-1332-83 | 00019133283 | 20 SYRINGE, PLASTIC in 1 CARTON (0019-1332-83) / 100 mL in 1 SYRINGE, PLASTICMarketed from Mar 4, 2012 | |
| 0019-1332-90 | 00019133290 | 20 SYRINGE, PLASTIC in 1 CARTON (0019-1332-90) / 100 mL in 1 SYRINGE, PLASTICMarketed from Mar 4, 2012 | |
| 0019-1332-91 | 00019133291 | 20 SYRINGE, PLASTIC in 1 CARTON (0019-1332-91) / 75 mL in 1 SYRINGE, PLASTICMarketed from Mar 4, 2012 |
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 300Suffix: 300
- Generic name (nonproprietary)
- ioversol
- Active ingredients
- Ioversol — 636 mg/mL
- Dosage form
- Injection
- Route
- Intra-arterial, Intravenous
- Labeler
- Liebel-Flarsheim Company LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019710
- Marketing start
- Listing expires
- Other FDA classes
- X-Ray Contrast Activity (Mechanism)
- Identifiers
- Product ID 0019-1332_1884aaeb-c174-4df7-a710-82d2b1869ad2SPL ID 1884aaeb-c174-4df7-a710-82d2b1869ad2SPL set ID 549d38db-d4ed-4708-8f76-7cdaa157063fUNII N3RIB7X24KUPC 0300191323521, 0300191333957, 0300191333872, 0300191323958, 0300191333902, 0300191323873, 0300191333780, 0300191323903
- 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
N400019133200followed by a unit qualifier and the quantityPackage 00019-1332-00. 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 (300, 320 mg iodine/mL) Peripheral Arteriography (300, 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 (300, 320, 350 mg iodine/mL) Venography (300, 320, 350 mg iodine/mL) Intravenous Excretory Urography (300, 320, 350 mg iodine/mL) Intravenous Digital Subtraction Angiograp…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 019710
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 320ioversol | Ioversol 678 mg/mL | InjectionIntra-arterial, Intravenous | Liebel-Flarsheim Company LLC | 0019-1323 |
| Optiray 350ioversol | Ioversol 741 mg/mL | InjectionIntra-arterial, Intravenous | Liebel-Flarsheim Company LLC | 0019-1333 |
- openFDA data updated
Med-Code stores this record for up to 24 hours before requesting it again.
Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.