NDC codes

FDA NDC Directory
Product NDC (as listed)11994-003Labeler and product segments. Claims need a package NDC.
Product NDC at billing width11994-0003Add 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
11994-003-201199400032020 VIAL in 1 BOX (11994-003-20) / 5 mL in 1 VIALMarketed from Dec 20, 1990

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
Kit for the Preparation of Technetium Tc99m Sestamibi
Generic name (nonproprietary)
tetrakis(2-methoxyisobutylisocyanide)copper(i) tetrafluoroborate
Active ingredients
Tetrakis(2-methoxyisobutylisocyanide)copper(I) tetrafluoroborate1 mg/mL
Dosage form
Injection, Powder, Lyophilized, For solution
Route
Intravenous
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 019785
Marketing start
Listing expires
Identifiers
Product ID 11994-003_517b7337-3529-4948-8d02-b8e2cf97a161SPL ID 517b7337-3529-4948-8d02-b8e2cf97a161SPL set ID 8c03a854-185a-45d7-883f-9f87e4750181UNII N6OU7HJ70P

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

N411994000320 followed by a unit qualifier and the quantity

Package 11994-0003-20. 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)

1. INDICATIONS AND USAGE Technetium Tc99m Sestamibi is a myocardial perfusion agent indicated for: detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects) evaluating myocardial function and developing information for use in patient management decisions Myocardial Imaging: Technetium Tc99m Sestamibi is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. Technetium Tc99m Sestamibi evaluation of

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 019785

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

FDA NDC Directory listings under NDA 019785
ProductStrengthForm · routeLabelerProduct NDC
Cardiolitetetrakis(2-methoxyisobutylisocyanide)copper(i) tetrafluoroborateTetrakis(2-methoxyisobutylisocyanide)copper(I) tetrafluoroborate 1 mg/mLInjection, Powder, Lyophilized, For solutionIntravenousSHINE SPECT USA, LLC87333-001
Cardiolitetetrakis(2-methoxyisobutylisocyanide)copper(i) tetrafluoroborateTetrakis(2-methoxyisobutylisocyanide)copper(I) tetrafluoroborate 1 mg/mLInjection, Powder, Lyophilized, For solutionIntravenousLantheus Medical Imaging, Inc.11994-001

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