Prescription drug · NDA
Lutathera (Lutetium lu 177 dotatate) NDC 69488-003
Lutetium oxodotreotide lu-177 10 mCi/mL · Injection · Intravenous · Advanced Accelerator Applications USA, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69488-003-01 | 69488000301 | 1 VIAL in 1 PACKAGE (69488-003-01) / 20.5 mL in 1 VIALMarketed from Jan 26, 2018 |
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)
- Lutathera
- Generic name (nonproprietary)
- lutetium lu 177 dotatate
- Active ingredients
- Lutetium oxodotreotide lu-177 — 10 mCi/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Advanced Accelerator Applications USA, IncNDC labeler code 69488
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208700
- Marketing start
- Listing expires
- Identifiers
- Product ID 69488-003_74d44dec-f079-43b7-94ac-989a948f53ecSPL ID 74d44dec-f079-43b7-94ac-989a948f53ecSPL set ID 72d1a024-00b7-418a-b36e-b2cb48f2ab55RxCUI 1999682, 1999687UNII AE221IM3BB
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.
- NDC on a medical claim
N469488000301followed by a unit qualifier and the quantityPackage 69488-0003-01. 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 .
Indications (excerpt from the label)
LUTATHERA is indicated for the treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors. LUTATHERA is a radiolabeled somatostatin analog indicated for the treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.
Excerpt only. Read the full label for complete information.
About NDC 69488-003
- What is NDC 69488-003?
- 69488-003 is the product NDC for Lutathera (lutetium lu 177 dotatate), Lutetium oxodotreotide lu-177 10 mCi/mL injection, listed with the FDA by Advanced Accelerator Applications USA, Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lutathera (Lutetium Lu 177 dotatate).
- What is the active ingredient?
- Lutetium oxodotreotide lu-177.
- Who is the labeler?
- Advanced Accelerator Applications USA, Inc, NDC labeler code 69488. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lutathera?
- 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.