What is NDC 70437-240?

70437-240 is the product NDC for Nerlynx (neratinib), Neratinib maleate anhydrous 40 mg/1 tablet, listed with the FDA by Puma Biotechnology, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Puma Biotechnology, Inc., NDC labeler code 70437. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Nerlynx?

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.

Nerlynx NDC 70437-240 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70437-240Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70437-0240Add 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 NDC	11-digit (billing)	Package
70437-240-18	70437024018	1 BOTTLE in 1 BOX (70437-240-18) / 180 TABLET in 1 BOTTLEMarketed from Jul 17, 2017
70437-240-26	70437024026	1 BOTTLE in 1 BOX (70437-240-26) / 126 TABLET in 1 BOTTLEMarketed from Jul 17, 2017
70437-240-33	70437024033	1 BOTTLE in 1 BOX (70437-240-33) / 133 TABLET in 1 BOTTLEMarketed from Jul 17, 2017

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): Nerlynx
Generic name (nonproprietary): neratinib
Active ingredients: Neratinib maleate anhydrous — 40 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Puma Biotechnology, Inc.NDC labeler code 70437
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 208051
Marketing start: Jul 17, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Kinase Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 70437-240_55a7b5be-747b-8497-e063-6294a90a8923SPL ID 55a7b5be-747b-8497-e063-6294a90a8923SPL set ID d1e41dcf-e82a-47c2-a0ad-6c6eef621834RxCUI 1940648, 1940654UNII 9RM7XY23ZSUPC 0370437240332, 0370437240264
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

N470437024018 followed by a unit qualifier and the quantity

Package 70437-0240-18. 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 Jul 2, 2026.

Indications (excerpt from the label)

NERLYNX is a kinase inhibitor indicated: As a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy. ( 1.1 ) In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting. ( 1.2 ) 1.1 Extended Adjuvant Treatment of Early-Stage Breast Cancer NERLYNX as a single agent is indicated for the extended adjuvant treatment of adult patients with early-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer, to follow adjuvant tr…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70437-240

What is NDC 70437-240?: 70437-240 is the product NDC for Nerlynx (neratinib), Neratinib maleate anhydrous 40 mg/1 tablet, listed with the FDA by Puma Biotechnology, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Nerlynx (Neratinib).
What is the active ingredient?: Neratinib maleate anhydrous.
Who is the labeler?: Puma Biotechnology, Inc., NDC labeler code 70437. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nerlynx?: 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.

Nerlynx (Neratinib) NDC 70437-240