Erlotinib (erlotinib hydrochloride) NDC 72485-217

NDC codes

FDA NDC Directory

Product NDC (as listed)72485-217Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72485-0217Add 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	Copy
72485-217-30	72485021730	1 BOTTLE in 1 BOX (72485-217-30) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from Nov 6, 2019

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): Erlotinib
Generic name (nonproprietary): erlotinib hydrochloride
Active ingredients: Erlotinib hydrochloride — 25 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Armas Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211960
Marketing start: Nov 6, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Protein Kinase Inhibitors (Mechanism)
Identifiers: Product ID 72485-217_35e3a161-752e-4479-b27c-3dc8efd3ca9eSPL ID 35e3a161-752e-4479-b27c-3dc8efd3ca9eSPL set ID 53cf8868-cfd8-4c6e-ad9d-3171ff1e4d8cRxCUI 603208UNII DA87705X9KUPC 0372485217304
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

N472485021730 followed by a unit qualifier and the quantity

Package 72485-0217-30. 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 Oct 25, 2019.

Indications (excerpt from the label)

Erlotinib tablet is a kinase inhibitor indicated for: The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving ﬁrst-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen ( 1.1 ) First-line treatment of patients with locally advanced, unrespectable or metastatic pancreatic cancer, in combination with gemcitabine. ( 1.2 ) Limitations of Use: Safety and efﬁcacy of erlotinib tablets have not been established in patients with NSCLC whose tumors hav…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 211960

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

FDA NDC Directory listings under ANDA 211960
Product	Strength	Form · route	Labeler	Product NDC
Erlotiniberlotinib hydrochloride	Erlotinib hydrochloride 100 mg/1	Tablet, Film coatedOral	Armas Pharmaceuticals Inc.	72485-218
Erlotiniberlotinib hydrochloride	Erlotinib hydrochloride 150 mg/1	Tablet, Film coatedOral	Armas Pharmaceuticals Inc.	72485-219