NDC codes

FDA NDC Directory
Product NDC (as listed)11994-017Labeler and product segments. Claims need a package NDC.
Product NDC at billing width11994-0017Add 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
11994-017-0111994001701119940017011 VIAL, GLASS in 1 CARTON (11994-017-01) / .35 mL in 1 VIAL, GLASSMarketed from Oct 1, 2020
11994-017-20119940017201199400172020 VIAL, GLASS in 1 CARTON (11994-017-20) / .35 mL in 1 VIAL, GLASSMarketed from Oct 1, 2020

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)
Definity Rt
Generic name (nonproprietary)
perflutren
Active ingredients
Perflutren — 6.52 mg/mL
Dosage form
Injection, Suspension
Route
Intravenous
Labeler
Lantheus Medical Imaging, Inc.NDC labeler code 11994
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 021064
Marketing start
Listing expires
Other FDA classes
Ultrasound Contrast Activity (Mechanism)
Identifiers
Product ID 11994-017_4d13e254-dcc7-460c-9adc-1c812562cef7SPL ID 4d13e254-dcc7-460c-9adc-1c812562cef7SPL set ID 7b9de6ab-a3ac-40c9-8103-139dc7a464a2UNII CK0N3WH0SR
Pharmacologic class
Contrast Agent for Ultrasound Imaging

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

N411994001701 followed by a unit qualifier and the quantity

Package 11994-0017-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

About NDC 11994-017

What is NDC 11994-017?
11994-017 is the product NDC for Definity Rt (perflutren), Perflutren 6.52 mg/mL injection, suspension, 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?
Definity Rt (Perflutren).
What is the active ingredient?
Perflutren.
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 Definity Rt?
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 NDA 021064

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

FDA NDC Directory listings under NDA 021064
ProductStrengthForm · routeLabelerProduct NDC
DefinityperflutrenPerflutren 6.52 mg/mLInjection, SuspensionIntravenousLantheus Medical Imaging, Inc.11994-011

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