Prescription drug · NDA
Tepmetko (Tepotinib hydrochloride) NDC 44087-5000
Tepotinib hydrochloride 225 mg/1 · Tablet · Oral · EMD Serono, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 44087-5000-3 | 4408750000344087500003 | 3 BLISTER PACK in 1 CARTON (44087-5000-3) / 10 TABLET in 1 BLISTER PACKMarketed from Feb 3, 2021 | |
| 44087-5000-6 | 4408750000644087500006 | 6 BLISTER PACK in 1 CARTON (44087-5000-6) / 10 TABLET in 1 BLISTER PACKMarketed from Feb 3, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Tepmetko
- Generic name (nonproprietary)
- tepotinib hydrochloride
- Active ingredients
- Tepotinib hydrochloride — 225 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- EMD Serono, Inc.NDC labeler code 44087
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 214096
- Marketing start
- Listing expires
- Other FDA classes
- Mesenchymal Epithelial Transition Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 44087-5000_d922de79-b0f0-4ed2-b551-c7a86ed72d7dSPL ID d922de79-b0f0-4ed2-b551-c7a86ed72d7dSPL set ID 80a0f1b9-071a-47f5-9e67-32d638a669dcRxCUI 2477266, 2477272UNII VY5YX2TQ1F
- Pharmacologic class
- Kinase Inhibitor
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
N444087500003followed by a unit qualifier and the quantityPackage 44087-5000-03. 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)
TEPMETKO is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition ( MET ) exon 14 skipping alterations. TEPMETKO is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition ( MET ) exon 14 skipping alterations. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 44087-5000
- What is NDC 44087-5000?
- 44087-5000 is the product NDC for Tepmetko (tepotinib hydrochloride), Tepotinib hydrochloride 225 mg/1 tablet, listed with the FDA by EMD Serono, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tepmetko (Tepotinib Hydrochloride).
- What is the active ingredient?
- Tepotinib hydrochloride.
- Who is the labeler?
- EMD Serono, Inc., NDC labeler code 44087. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tepmetko?
- 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.