Prescription drug · NDA
Lipiodol (Ethiodized oil) NDC 67684-1901
Ethiodized oil 480 mg/mL · Injection · Intra-arterial, Intralymphatic, Intrauterine · Guerbet LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67684-1901-1 | 67684190101 | 1 AMPULE in 1 CARTON (67684-1901-1) / 10 mL in 1 AMPULEMarketed from Mar 21, 2014 | |
| 67684-1901-2 | 67684190102 | 1 VIAL in 1 CARTON (67684-1901-2) / 10 mL in 1 VIALMarketed from Sep 28, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Lipiodol
- Generic name (nonproprietary)
- ethiodized oil
- Active ingredients
- Ethiodized oil — 480 mg/mL
- Dosage form
- Injection
- Route
- Intra-arterial, Intralymphatic, Intrauterine
- Labeler
- Guerbet LLCNDC labeler code 67684
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 009190
- Marketing start
- Listing expires
- Identifiers
- Product ID 67684-1901_46155dba-f0cf-22b8-e063-6294a90a5997SPL ID 46155dba-f0cf-22b8-e063-6294a90a5997SPL set ID 511d1f64-5cb9-4baa-a123-96205467e59aUNII KZW0R0686Q
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
N467684190101followed by a unit qualifier and the quantityPackage 67684-1901-01. 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)
Lipiodol is an oil-based radio-opaque contrast agent indicated for: hysterosalpingography in adults lymphography in adult and pediatric patients selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC) Lipiodol is an oil-based radiopaque contrast agent indicated for: hysterosalpingography in adults lymphography in adult and pediatric patients selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC)
Excerpt only. Read the full label for complete information.
About NDC 67684-1901
- What is NDC 67684-1901?
- 67684-1901 is the product NDC for Lipiodol (ethiodized oil), Ethiodized oil 480 mg/mL injection, listed with the FDA by Guerbet LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lipiodol (Ethiodized oil).
- What is the active ingredient?
- Ethiodized oil.
- Who is the labeler?
- Guerbet LLC, NDC labeler code 67684. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lipiodol?
- 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.