Gefitinib
- Product NDC
- 0480-4053
- 11-digit product format
- 004804053
- Labeler code
- 0480
- Product ID
- 0480-4053_94ce2dc4-2b69-4c50-b53e-21e24062903d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gefitinib
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals, Inc.
- Application
- ANDA208913
- Marketing category
- ANDA
- Marketing start
- 2023-06-21
- 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
- Gefitinib
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0480-4053-56 | Gefitinib | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0480-4053 | GEFITINIB TABLET, FILM COATED [TEVA PHARMACEUTICALS, INC.] | 5 | Current NDC, 1 package rows | 20241215_3dd135f0-5db1-4236-9756-04533b66dc9d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0480-4053-56 | 00480405356 | 30 TABLET, FILM COATED in 1 BOTTLE (0480-4053-56) | 2023-06-21 | No | No | Historical |