NDC codes

FDA NDC Directory
Product NDC (as listed)0002-2980Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00002-2980Add 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
0002-2980-2600002298026120 CAPSULE in 1 BOTTLE (0002-2980-26)Marketed from May 8, 2020
0002-2980-600000229806060 CAPSULE in 1 BOTTLE (0002-2980-60)Marketed from May 8, 2020

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Retevmo
Generic name (nonproprietary)
selpercatinib
Active ingredients
Selpercatinib — 80 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Eli Lilly and CompanyNDC labeler code 0002
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 213246
Marketing start
Listing expires
Other FDA classes
Breast Cancer Resistance Protein Inhibitors (Mechanism)Cytochrome P450 2C8 Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Multidrug and Toxin Extrusion Transporter 1 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)Rearranged during Transfection (RET) Inhibitors (Mechanism)
Identifiers
Product ID 0002-2980_7481a510-805c-4f99-b6ae-7b44e70f5f55SPL ID 7481a510-805c-4f99-b6ae-7b44e70f5f55
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

N400002298026 followed by a unit qualifier and the quantity

Package 00002-2980-26. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 0002-2980

What is NDC 0002-2980?
0002-2980 is the product NDC for Retevmo (selpercatinib), Selpercatinib 80 mg/1 capsule, listed with the FDA by Eli Lilly and Company. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Retevmo (Selpercatinib).
What is the active ingredient?
Selpercatinib.
Who is the labeler?
Eli Lilly and Company, NDC labeler code 0002. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Retevmo?
5 other product NDCs are listed under this name. See all Retevmo NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Retevmo NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
RetevmoselpercatinibSelpercatinib 160 mg/1Tablet, CoatedOralEli Lilly and Company0002-556200002-5562-60
RetevmoselpercatinibSelpercatinib 120 mg/1Tablet, CoatedOralEli Lilly and Company0002-612000002-6120-60
RetevmoselpercatinibSelpercatinib 40 mg/1Tablet, CoatedOralEli Lilly and Company0002-534000002-5340-60
RetevmoselpercatinibSelpercatinib 80 mg/1Tablet, CoatedOralEli Lilly and Company0002-608200002-6082-60
RetevmoselpercatinibSelpercatinib 40 mg/1CapsuleOralEli Lilly and Company0002-397700002-3977-60

Other NDCs under NDA 213246

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 213246
ProductStrengthForm · routeLabelerProduct NDC
RetevmoselpercatinibSelpercatinib 40 mg/1CapsuleOralEli Lilly and Company0002-3977

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