What is NDC 11994-011?

11994-011 is the product NDC for Definity (perflutren), Perflutren 6.52 mg/mL injection, suspension, listed with the FDA by Lantheus Medical Imaging, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

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?

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.

Definity NDC 11994-011 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)11994-011Labeler and product segments. Claims need a package NDC.

Product NDC at billing width11994-0011Add 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 NDC	11-digit (billing)	Package
11994-011-01	11994001101	1 VIAL, GLASS in 1 CARTON (11994-011-01) / 1.5 mL in 1 VIAL, GLASSMarketed from Jul 31, 2001
11994-011-04	11994001104	4 VIAL, GLASS in 1 CARTON (11994-011-04) / 1.5 mL in 1 VIAL, GLASSMarketed from Jul 31, 2001
11994-011-16	11994001116	16 VIAL, GLASS in 1 CARTON (11994-011-16) / 1.5 mL in 1 VIAL, GLASSMarketed from Jul 31, 2001

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
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: Jul 31, 2001
Listing expires: Dec 31, 2026
Other FDA classes: Ultrasound Contrast Activity (Mechanism)
Identifiers: Product ID 11994-011_8b5860ab-6714-4cf0-8679-f7c439fe5131SPL ID 8b5860ab-6714-4cf0-8679-f7c439fe5131SPL set ID 8ab9c79c-1b5c-4e86-899c-cc74686f070aUNII 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

N411994001101 followed by a unit qualifier and the quantity

Package 11994-0011-01. 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

Current FDA label (SPL), effective Mar 13, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

DEFINITY is indicated, after activation, for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. DEFINITY is an ultrasound contrast agent indicated, after activation, for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 11994-011

What is NDC 11994-011?: 11994-011 is the product NDC for Definity (perflutren), Perflutren 6.52 mg/mL injection, suspension, listed with the FDA by Lantheus Medical Imaging, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Definity (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?: 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
Product	Strength	Form · route	Labeler	Product NDC
Definity Rtperflutren	Perflutren 6.52 mg/mL	Injection, SuspensionIntravenous	Lantheus Medical Imaging, Inc.	11994-017

Definity (Perflutren) NDC 11994-011