NDC codes

FDA NDC Directory
Product NDC (as listed)44087-5000Labeler and product segments. Claims need a package NDC.
Product NDC at billing width44087-5000Add 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 NDC11-digit (billing)PackageCopy
44087-5000-344087500003440875000033 BLISTER PACK in 1 CARTON (44087-5000-3) / 10 TABLET in 1 BLISTER PACKMarketed from Feb 3, 2021
44087-5000-644087500006440875000066 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

N444087500003 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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