Prescription drug · NDA
Lynkuet (Elinzanetant) NDC 50419-475
Elinzanetant 60 mg/1 · Capsule · Oral · Bayer HealthCare Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50419-475-05 | 50419047505 | 5 BLISTER PACK in 1 CARTON (50419-475-05) / 12 CAPSULE in 1 BLISTER PACK (50419-475-01)Marketed from Oct 24, 2025 | |
| 50419-475-72 | 50419047572 | 2 BLISTER PACK in 1 CARTON (50419-475-72) / 12 CAPSULE in 1 BLISTER PACK (50419-475-71)Marketed from Oct 24, 2025 · Sample package | |
| 50419-475-73 | 50419047573 | 1 BLISTER PACK in 1 CARTON (50419-475-73) / 12 CAPSULE in 1 BLISTER PACK (50419-475-71)Marketed from May 7, 2026 |
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)
- Lynkuet
- Generic name (nonproprietary)
- elinzanetant
- Active ingredients
- Elinzanetant — 60 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Bayer HealthCare Pharmaceuticals Inc.NDC labeler code 50419
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 219469
- Marketing start
- Listing expires
- Identifiers
- Product ID 50419-475_35894d94-556e-4bb6-ada9-9d63788de46aSPL ID 35894d94-556e-4bb6-ada9-9d63788de46aSPL set ID f42884ff-7dff-419c-8a0c-affe2ed73818RxCUI 2725516, 2725522UNII NZW2BOW35N
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450419047505followed by a unit qualifier and the quantityPackage 50419-0475-05. 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)
LYNKUET is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. LYNKUET is a neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 50419-475
- What is NDC 50419-475?
- 50419-475 is the product NDC for Lynkuet (elinzanetant), Elinzanetant 60 mg/1 capsule, listed with the FDA by Bayer HealthCare Pharmaceuticals Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lynkuet (Elinzanetant).
- What is the active ingredient?
- Elinzanetant.
- Who is the labeler?
- Bayer HealthCare Pharmaceuticals Inc., NDC labeler code 50419. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lynkuet?
- 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.