Gefitinib NDC 69339-168

NDC codes

FDA NDC Directory

Product NDC (as listed)69339-168Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69339-0168Add 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
69339-168-03	69339016803	30 TABLET, FILM COATED in 1 BOTTLE (69339-168-03)Marketed from Jun 5, 2023

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): Gefitinib
Generic name (nonproprietary): gefitinib
Active ingredients: Gefitinib — 250 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Natco Pharma USA LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212827
Marketing start: Jun 5, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Protein Kinase Inhibitors (Mechanism)
Identifiers: Product ID 69339-168_5a5b1155-767f-4e57-bd89-c67c80b40972SPL ID 5a5b1155-767f-4e57-bd89-c67c80b40972SPL set ID 1a3c0ce7-06a1-4e04-9106-14ddb2a866a5RxCUI 349472UNII S65743JHBSUPC 0369339168035
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

N469339016803 followed by a unit qualifier and the quantity

Package 69339-0168-03. 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 Mar 10, 2026.

Indications (excerpt from the label)

Gefitinib tablets are indicated for the first-line 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 [see Clinical Studies (14) ]. Limitation of Use: Safety and efficacy of gefitinib tablets have not been established in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations [see Clinical Studies (14) ]. Gefitinib tablets are tyrosine kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung can…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)