Prescription drug · BLA
Volumex (Iodinated i-131 albumin) NDC 50914-7720
Human serum albumin i-131 .025 mCi/mL · Injection, Solution · Intravenous · Iso-Tex Diagnostics, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50914-7720-8 | 50914772008 | 1 mL in 1 SYRINGE, PLASTIC (50914-7720-8)Marketed from Aug 1, 1993 |
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)
- Volumex
- Generic name (nonproprietary)
- iodinated i-131 albumin
- Active ingredients
- Human serum albumin i-131 — .025 mCi/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Iso-Tex Diagnostics, Inc.NDC labeler code 50914
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 017837
- Marketing start
- Listing expires
- Other FDA classes
- Radiopharmaceutical Activity (Mechanism)
- Identifiers
- Product ID 50914-7720_1f46b3df-897f-4a96-9feb-9e5c9dd2864fSPL ID 1f46b3df-897f-4a96-9feb-9e5c9dd2864fSPL set ID 812240e4-fc28-46c2-92f3-1ba4e029645aUNII ACH35131L1
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
N450914772008followed by a unit qualifier and the quantityPackage 50914-7720-08. 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 Volumex (Iodinated I 131 Allbumin injection) is indicated for use in determinations of total blood and plasma volumes and in protein turnover studies
Excerpt only. Read the full label for complete information.
About NDC 50914-7720
- What is NDC 50914-7720?
- 50914-7720 is the product NDC for Volumex (iodinated i-131 albumin), Human serum albumin i-131 .025 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?
- Volumex (Iodinated I-131 Albumin).
- What is the active ingredient?
- Human serum albumin i-131.
- 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 Volumex?
- 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.
Other NDCs under BLA 017837
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 |
|---|---|---|---|---|
| Megatopeiodinated i-131 albumin | Human serum albumin i-131 1 mCi/mL | Injection, SolutionIntravenous | Iso-Tex Diagnostics, Inc. | 50914-7731 |