Prescription drug · NDA
Glofil-125 (Sodium iothalamate i-125 injection) NDC 50914-7729
Iothalamate sodium i-125 .275 mCi/mL · Injection, Solution · Intravenous · Iso-Tex Diagnostics, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50914-7729-2 | 50914772902 | 1 VIAL, MULTI-DOSE in 1 BOX (50914-7729-2) / 4 mL in 1 VIAL, MULTI-DOSEMarketed from May 1, 1983 |
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)
- Glofil-125
- Generic name (nonproprietary)
- sodium iothalamate i-125 injection
- Active ingredients
- Iothalamate sodium i-125 — .275 mCi/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Iso-Tex Diagnostics, Inc.NDC labeler code 50914
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 017279
- Marketing start
- Listing expires
- Other FDA classes
- Radiopharmaceutical Activity (Mechanism)
- Identifiers
- Product ID 50914-7729_03a98b4c-213b-4537-8d3a-aaa9f9f1cc9bSPL ID 03a98b4c-213b-4537-8d3a-aaa9f9f1cc9bSPL set ID 7f250086-2837-484b-9674-e09856b34cb0UNII 31J5U3Q9ZNUPC 0050914772920
- Pharmacologic class
- Radioactive Diagnostic 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
N450914772902followed by a unit qualifier and the quantityPackage 50914-7729-02. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE GLOFIL-125 (Sodium Iothalamate I-125 Injection) is indicated for evaluation of glomerular filtration in the diagnosis or monitoring of patients with renal disease.
Excerpt only. Read the full label for complete information.
About NDC 50914-7729
- What is NDC 50914-7729?
- 50914-7729 is the product NDC for Glofil-125 (sodium iothalamate i-125 injection), Iothalamate sodium i-125 .275 mCi/mL injection, solution, listed with the FDA by Iso-Tex Diagnostics, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Glofil-125 (Sodium Iothalamate I-125 injection).
- What is the active ingredient?
- Iothalamate sodium i-125.
- Who is the labeler?
- Iso-Tex Diagnostics, Inc., NDC labeler code 50914. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Glofil-125?
- 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.