NDC codes

FDA NDC Directory
Product NDC (as listed)0407-1416Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00407-1416Add 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
0407-1416-120040714161210 BOTTLE, PLASTIC in 1 BOX (0407-1416-12) / 500 mL in 1 BOTTLE, PLASTICMarketed from Apr 27, 2018

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)
Omnipaque
Generic name (nonproprietary)
iohexol
Active ingredients
Iohexol — 12 mg/mL
Dosage form
Solution
Route
Oral
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 018956
Marketing start
Listing expires
Other FDA classes
X-Ray Contrast Activity (Mechanism)
Identifiers
Product ID 0407-1416_61f3e388-89bf-43d6-ad51-b620fff561fbSPL ID 61f3e388-89bf-43d6-ad51-b620fff561fbSPL set ID eee15ebe-d349-4497-acef-6abe7a8247fbUNII 4419T9MX03
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400407141612 followed by a unit qualifier and the quantity

Package 00407-1416-12. 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)

OMNIPAQUE is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, and body cavity imaging procedures in adults and pediatric patients. ( 1 ) 1.1 Intrathecal Procedures ‡ OMNIPAQUE is indicated for: Myelography and computerized tomography (CT) myelography (lumbar, thoracic, cervical, total columnar) in adults and pediatric patients aged 2 weeks and older CT cisternography in adults and pediatric patients aged 2 weeks and older 1.2 Intra-arterial Procedures ‡ OMNIPAQUE is indicated for: Cardiac ventriculography in adults and pediatric patients Aortography including studies of aorta and its branches in adults and pediatric patients …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 018956

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

FDA NDC Directory listings under NDA 018956
ProductStrengthForm · routeLabelerProduct NDC
OmnipaqueiohexolIohexol 240 mg/mLInjection, SolutionIntra-articular, Intrathecal, Intravascular, Intravenous, Oral, RectalMedical Purchasing Solutions, LLC71872-7369
OmnipaqueiohexolIohexol 300 mg/mLInjection, SolutionIntra-articular, Intrathecal, Intravascular, Intravenous, Oral, RectalMedical Purchasing Solutions, LLC71872-7370
OmnipaqueiohexolIohexol 140 mg/mLInjection, SolutionIntravascular, IntravenousGE Healthcare Inc.0407-1401
OmnipaqueiohexolIohexol 180 mg/mLInjection, SolutionIntrathecal, Oral, RectalGE Healthcare Inc.0407-1411
OmnipaqueiohexolIohexol 240 mg/mLInjection, SolutionIntra-articular, Intrathecal, Intravascular, Intravenous, Oral, RectalGE Healthcare Inc.0407-1412
OmnipaqueiohexolIohexol 300 mg/mLInjection, SolutionIntra-articular, Intrathecal, Intravascular, Intravenous, Oral, RectalGE Healthcare Inc.0407-1413
OmnipaqueiohexolIohexol 350 mg/mLInjection, SolutionIntra-articular, Intravascular, Intravenous, OralGE Healthcare Inc.0407-1414
OmnipaqueiohexolIohexol 9 mg/mLSolutionOralGE Healthcare Inc.0407-1415

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