IRESSA
- Product NDC
- 0310-0482
- 11-digit product format
- 003100482
- Labeler code
- 0310
- Product ID
- 0310-0482_508019dd-61d5-4459-9476-3f5897143f0c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gefitinib
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- AstraZeneca Pharmaceuticals LP
- Application
- NDA206995
- Marketing category
- NDA
- Marketing start
- 2015-07-13
- Substance
- GEFITINIB
- Active strength
- 250 mg/1
- Pharmacologic classes
- Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- IRESSA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GEFITINIB | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | S65743JHBS |
| Rxcui | 349472, 402091 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0310-0482-30 | IRESSA | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 19 |
| 0310-0482-93 | IRESSA | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 19 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0310-0482 | IRESSA (GEFITINIB) TABLET, COATED [ASTRAZENECA PHARMACEUTICALS LP] | 18 | Current NDC, Legacy NDC, 2 package rows | 20240517_827d60e8-7e07-41b7-c28b-49ef1c4a5a41.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0310-0482-30 | 00310048230 | 30 TABLET, COATED in 1 BOTTLE (0310-0482-30) | 2015-07-13 | 0000-00-00 | No | No | Current |
| 0310-0482-93 | 00310048293 | 30 in 1 BOTTLE | | | | | Historical |