NDC codes

FDA NDC Directory
Product NDC (as listed)11994-001Labeler and product segments. Claims need a package NDC.
Product NDC at billing width11994-0001Add 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
11994-001-20119940001201199400012020 VIAL in 1 BOX (11994-001-20) / 5 mL in 1 VIALMarketed from Feb 28, 2008
11994-001-5511994000155119940001555 VIAL in 1 BOX (11994-001-55) / 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)
Cardiolite
Generic name (nonproprietary)
tetrakis(2-methoxyisobutylisocyanide)copper(i) tetrafluoroborate
Dosage form
Injection, Powder, Lyophilized, For solution
Route
Intravenous
Labeler
Lantheus Medical Imaging, Inc.NDC labeler code 11994
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 019785
Marketing start
Listing expires
Identifiers
Product ID 11994-001_d515f49a-8eb4-42f3-a7ee-1634a4804ca5SPL ID d515f49a-8eb4-42f3-a7ee-1634a4804ca5SPL set ID 49662def-2fb9-47b2-8467-ca56f6006167UNII 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

N411994000120 followed by a unit qualifier and the quantity

Package 11994-0001-20. 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 CARDIOLITE® 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: CARDIOLITE ® , Kit for the Preparation of Technetium Tc99m Sestamibi for Injection, 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.…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 11994-001

What is NDC 11994-001?
11994-001 is the product NDC for Cardiolite, Tetrakis(2-methoxyisobutylisocyanide)copper(I) tetrafluoroborate 1 mg/mL injection, powder, lyophilized, for solution, listed with the FDA by Lantheus Medical Imaging, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Cardiolite (Tetrakis(2-methoxyisobutylisocyanide)copper(I) tetrafluoroborate).
What is the active ingredient?
Tetrakis(2-methoxyisobutylisocyanide)copper(I) tetrafluoroborate.
Who is the labeler?
Lantheus Medical Imaging, Inc., NDC labeler code 11994. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cardiolite?
1 other product NDC are listed under this name. See all Cardiolite NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Cardiolite NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Cardiolitetetrakis(2-methoxyisobutylisocyanide)copper(i) tetrafluoroborateTetrakis(2-methoxyisobutylisocyanide)copper(I) tetrafluoroborate 1 mg/mLInjection, Powder, Lyophilized, For solutionIntravenousSHINE SPECT USA, LLC87333-00187333-0001-2087333-0001-55

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
Kit for the Preparation of Technetium Tc99m Sestamibitetrakis(2-methoxyisobutylisocyanide)copper(i) tetrafluoroborateTetrakis(2-methoxyisobutylisocyanide)copper(I) tetrafluoroborate 1 mg/mLInjection, Powder, Lyophilized, For solutionIntravenousLantheus Medical Imaging, Inc.11994-003

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in