NDC codes

FDA NDC Directory
Product NDC (as listed)50914-7731Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50914-7731Add 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
50914-7731-4509147731048 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
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.

How CPT relates to drug billing

NDC on a medical claim

N450914773104 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 017837

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

FDA NDC Directory listings under BLA 017837
ProductStrengthForm · routeLabelerProduct NDC
Volumexiodinated i-131 albuminHuman serum albumin i-131 .025 mCi/mLInjection, SolutionIntravenousIso-Tex Diagnostics, Inc.50914-7720

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