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
Product NDC (as listed)0019-1323Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00019-1323Add 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
0019-1323-000001913230020 SYRINGE, PLASTIC in 1 CARTON (0019-1323-00) / 100 mL in 1 SYRINGE, PLASTICMarketed from Mar 4, 2012
0019-1323-020001913230225 VIAL, GLASS in 1 CARTON (0019-1323-02) / 20 mL in 1 VIAL, GLASSMarketed from Mar 4, 2012
0019-1323-040001913230425 VIAL, GLASS in 1 CARTON (0019-1323-04) / 30 mL in 1 VIAL, GLASSMarketed from Mar 4, 2012
0019-1323-060001913230625 BOTTLE, GLASS in 1 CARTON (0019-1323-06) / 50 mL in 1 BOTTLE, GLASSMarketed from Mar 4, 2012
0019-1323-110001913231112 BOTTLE, GLASS in 1 CARTON (0019-1323-11) / 100 mL in 1 BOTTLE, GLASSMarketed from Mar 4, 2012
0019-1323-160001913231612 BOTTLE, GLASS in 1 CARTON (0019-1323-16) / 150 mL in 1 BOTTLE, GLASSMarketed from Mar 4, 2012
0019-1323-210001913232112 BOTTLE, GLASS in 1 CARTON (0019-1323-21) / 200 mL in 1 BOTTLE, GLASSMarketed from Mar 4, 2012
0019-1323-270001913232720 SYRINGE, PLASTIC in 1 CARTON (0019-1323-27) / 125 mL in 1 SYRINGE, PLASTICMarketed from Mar 4, 2012
0019-1323-520001913235220 SYRINGE, PLASTIC in 1 CARTON (0019-1323-52) / 50 mL in 1 SYRINGE, PLASTICMarketed from Mar 4, 2012
0019-1323-550001913235520 SYRINGE, PLASTIC in 1 CARTON (0019-1323-55) / 50 mL in 1 SYRINGE, PLASTICMarketed from Mar 4, 2012
0019-1323-700001913237020 SYRINGE, PLASTIC in 1 CARTON (0019-1323-70) / 30 mL in 1 SYRINGE, PLASTICMarketed from Mar 4, 2012
0019-1323-730001913237320 SYRINGE, PLASTIC in 1 CARTON (0019-1323-73) / 30 mL in 1 SYRINGE, PLASTICMarketed from Mar 4, 2012
0019-1323-750001913237520 SYRINGE, PLASTIC in 1 CARTON (0019-1323-75) / 50 mL in 1 SYRINGE, PLASTICMarketed from Mar 4, 2012
0019-1323-770001913237720 SYRINGE, PLASTIC in 1 CARTON (0019-1323-77) / 50 mL in 1 SYRINGE, PLASTICMarketed from Mar 4, 2012
0019-1323-780001913237820 SYRINGE, PLASTIC in 1 CARTON (0019-1323-78) / 50 mL in 1 SYRINGE, PLASTICMarketed from Mar 4, 2012
0019-1323-810001913238120 SYRINGE, PLASTIC in 1 CARTON (0019-1323-81) / 125 mL in 1 SYRINGE, PLASTICMarketed from Mar 4, 2012
0019-1323-830001913238320 SYRINGE, PLASTIC in 1 CARTON (0019-1323-83) / 100 mL in 1 SYRINGE, PLASTICMarketed from Mar 4, 2012
0019-1323-850001913238520 SYRINGE, PLASTIC in 1 CARTON (0019-1323-85) / 75 mL in 1 SYRINGE, PLASTICMarketed from Mar 4, 2012
0019-1323-870001913238720 SYRINGE, PLASTIC in 1 CARTON (0019-1323-87) / 125 mL in 1 SYRINGE, PLASTICMarketed from Mar 4, 2012
0019-1323-900001913239020 SYRINGE, PLASTIC in 1 CARTON (0019-1323-90) / 100 mL in 1 SYRINGE, PLASTICMarketed from Mar 4, 2012
0019-1323-910001913239120 SYRINGE, PLASTIC in 1 CARTON (0019-1323-91) / 75 mL in 1 SYRINGE, PLASTICMarketed from Mar 4, 2012
0019-1323-950001913239520 SYRINGE, PLASTIC in 1 CARTON (0019-1323-95) / 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 320Suffix: 320
Generic name (nonproprietary)
ioversol
Active ingredients
Ioversol — 678 mg/mL
Dosage form
Injection
Route
Intra-arterial, Intravenous
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 0019-1323_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.

How CPT relates to drug billing

NDC on a medical claim

N400019132300 followed by a unit qualifier and the quantity

Package 00019-1323-00. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 019710

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 019710
ProductStrengthForm · routeLabelerProduct NDC
Optiray 300ioversolIoversol 636 mg/mLInjectionIntra-arterial, IntravenousLiebel-Flarsheim Company LLC0019-1332
Optiray 350ioversolIoversol 741 mg/mLInjectionIntra-arterial, IntravenousLiebel-Flarsheim Company LLC0019-1333

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