Prescription drug · NDA
Neurolite (Bicisate dihydrochloride) NDC 11994-006
Kit · Lantheus Medical Imaging, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11994-006-02 | 11994000602 | 2 KIT in 1 PACKAGE, COMBINATION (11994-006-02) / 1 KIT in 1 KIT * 1 INJECTION in 1 VIAL (11994-002-01) * 1 mL in 1 VIAL (11994-004-01)Marketed from Nov 23, 1994 | |
| 11994-006-05 | 11994000605 | 5 KIT in 1 PACKAGE, COMBINATION (11994-006-05) / 1 KIT in 1 KIT * 1 INJECTION in 1 VIAL (11994-002-01) * 1 mL in 1 VIAL (11994-004-01)Marketed from Nov 23, 1994 |
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)
- Neurolite
- Generic name (nonproprietary)
- bicisate dihydrochloride
- Dosage form
- Kit
- Labeler
- Lantheus Medical Imaging, Inc.NDC labeler code 11994
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020256
- Marketing start
- Listing expires
- Identifiers
- Product ID 11994-006_6a6da20d-b33c-4e9e-98da-8d9b7cc963caSPL ID 6a6da20d-b33c-4e9e-98da-8d9b7cc963caSPL set ID f9adbcd5-1ac1-42d8-b18a-a76c9204014c
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.
- NDC on a medical claim
N411994000602followed by a unit qualifier and the quantityPackage 11994-0006-02. 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 Neurolite single photon emission computerized tomography (SPECT) is indicated as an adjunct to conventional CT or MRI imaging in the localization of stroke in patients in whom stroke has already been diagnosed. Neurolite is not indicated for assessment of functional viability of brain tissue. Also, Neurolite is not indicated for distinguishing between stroke and other brain lesions.
Excerpt only. Read the full label for complete information.
About NDC 11994-006
- What is NDC 11994-006?
- 11994-006 is the product NDC for Neurolite (bicisate dihydrochloride) kit, 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?
- Neurolite (Bicisate dihydrochloride).
- 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 Neurolite?
- 1 other product NDC are listed under this name. See all Neurolite NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Neurolite products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Neurolitebicisate dihydrochloride | — | Kit | SHINE SPECT USA, LLC | 87333-006 | 87333-0006-0287333-0006-05 |
Other NDCs under NDA 020256
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Neurolitebicisate dihydrochloride | — | Kit | SHINE SPECT USA, LLC | 87333-006 |