Prescription drug · BLA
Megatope (iodinated i-131 albumin) NDC 50914-7731
Human serum albumin i-131 1 mCi/mL · Injection, Solution · Intravenous · Iso-Tex Diagnostics, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50914-7731-4 | 50914773104 | 8 mL in 1 VIAL, MULTI-DOSE (50914-7731-4)Marketed from May 21, 1996 |
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)
- Megatope
- Generic name (nonproprietary)
- iodinated i-131 albumin
- Active ingredients
- Human serum albumin i-131 — 1 mCi/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Iso-Tex Diagnostics, Inc.
- 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 50914-7731_a0a63fb3-6957-4446-8bf0-67c91325f753SPL ID a0a63fb3-6957-4446-8bf0-67c91325f753SPL set ID 62ca4278-8cc9-46b7-8f3c-303ce6a9c155UNII 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
N450914773104followed by a unit qualifier and the quantityPackage 50914-7731-04. 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 MEGATOPE is indicated in adults for use in determinations of total blood and plasma volumes.
Excerpt only. Read the full label for complete information.
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 |
|---|---|---|---|---|
| Volumexiodinated i-131 albumin | Human serum albumin i-131 .025 mCi/mL | Injection, SolutionIntravenous | Iso-Tex Diagnostics, Inc. | 50914-7720 |