What is NDC 0310-0482?

0310-0482 is the product NDC for Iressa (gefitinib), Gefitinib 250 mg/1 tablet, coated, listed with the FDA by AstraZeneca Pharmaceuticals LP. It has 1 package NDC, shown above in 10- and 11-digit form.

AstraZeneca Pharmaceuticals LP, NDC labeler code 0310. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Iressa?

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.

Iressa NDC 0310-0482 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0310-0482Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00310-0482Add 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
0310-0482-30	00310048230	30 TABLET, COATED in 1 BOTTLE (0310-0482-30)Marketed from Jul 13, 2015

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): Iressa
Generic name (nonproprietary): gefitinib
Active ingredients: Gefitinib — 250 mg/1
Dosage form: Tablet, Coated
Route: Oral
Labeler: AstraZeneca Pharmaceuticals LPNDC labeler code 0310
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 206995
Marketing start: Jul 13, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Protein Kinase Inhibitors (Mechanism)
Identifiers: Product ID 0310-0482_508019dd-61d5-4459-9476-3f5897143f0cSPL ID 508019dd-61d5-4459-9476-3f5897143f0cSPL set ID 827d60e8-7e07-41b7-c28b-49ef1c4a5a41RxCUI 349472, 402091UNII S65743JHBS
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

N400310048230 followed by a unit qualifier and the quantity

Package 00310-0482-30. 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 Feb 28, 2023.

Indications (excerpt from the label)

IRESSA is 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 IRESSA 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) ] . IRESSA is a tyrosine kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have e…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0310-0482

What is NDC 0310-0482?: 0310-0482 is the product NDC for Iressa (gefitinib), Gefitinib 250 mg/1 tablet, coated, listed with the FDA by AstraZeneca Pharmaceuticals LP. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Iressa (Gefitinib).
What is the active ingredient?: Gefitinib.
Who is the labeler?: AstraZeneca Pharmaceuticals LP, NDC labeler code 0310. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Iressa?: 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.

Iressa (Gefitinib) NDC 0310-0482