What is NDC 67184-0531?

67184-0531 is the product NDC for Gefitinib, Gefitinib 250 mg/1 tablet, coated, listed with the FDA by Qilu Pharmaceutical Co., Ltd.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Qilu Pharmaceutical Co., Ltd., NDC labeler code 67184. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Gefitinib?

3 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Gefitinib NDC 67184-0531 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)67184-0531Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67184-0531Add 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
67184-0531-1	67184053101	30 TABLET, COATED in 1 BOTTLE (67184-0531-1)Marketed from Feb 13, 2023
67184-0531-2	67184053102	500 TABLET, COATED in 1 BOTTLE (67184-0531-2)Marketed from Feb 13, 2023
67184-0531-3	67184053103	3 BLISTER PACK in 1 CARTON (67184-0531-3) / 10 TABLET, COATED in 1 BLISTER PACKMarketed from Feb 13, 2023

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): Gefitinib
Generic name (nonproprietary): gefitinib
Active ingredients: Gefitinib — 250 mg/1
Dosage form: Tablet, Coated
Route: Oral
Labeler: Qilu Pharmaceutical Co., Ltd.NDC labeler code 67184
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211591
Marketing start: Feb 13, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Protein Kinase Inhibitors (Mechanism)
Identifiers: Product ID 67184-0531_8aa73f33-2813-4dfa-939f-e4291081449aSPL ID 8aa73f33-2813-4dfa-939f-e4291081449aSPL set ID 0afc12dd-12f8-4def-9027-f38412a862b9RxCUI 349472UNII S65743JHBSUPC 0367184053124
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

N467184053101 followed by a unit qualifier and the quantity

Package 67184-0531-01. 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 Feb 22, 2023.

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 a tyrosine kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67184-0531

What is NDC 67184-0531?: 67184-0531 is the product NDC for Gefitinib, Gefitinib 250 mg/1 tablet, coated, listed with the FDA by Qilu Pharmaceutical Co., Ltd.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Gefitinib.
What is the active ingredient?: Gefitinib.
Who is the labeler?: Qilu Pharmaceutical Co., Ltd., NDC labeler code 67184. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Gefitinib?: 3 other product NDCs are listed under this name. See all Gefitinib 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 Gefitinib NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Gefitinib	Gefitinib 250 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals, Inc.	0480-4053	00480-4053-56
Gefitinib	Gefitinib 250 mg/1	Tablet, Film coatedOral	Natco Pharma USA LLC	69339-168	69339-0168-03
Gefitinib	Gefitinib 250 mg/1	Tablet, CoatedOral	Ingenus Pharmaceuticals, LLC	50742-366	50742-0366-30

Other NDCs under ANDA 211591

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

FDA NDC Directory listings under ANDA 211591
Product	Strength	Form · route	Labeler	Product NDC
Gefitinib	Gefitinib 250 mg/1	Tablet, CoatedOral	Ingenus Pharmaceuticals, LLC	50742-366