Gefitinib
- Product NDC
- 67184-0531
- 11-digit product format
- 671840531
- Labeler code
- 67184
- Product ID
- 67184-0531_8aa73f33-2813-4dfa-939f-e4291081449a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gefitinib
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Qilu Pharmaceutical Co., Ltd.
- Application
- ANDA211591
- Marketing category
- ANDA
- Marketing start
- 2023-02-13
- 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
- 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 |
|---|
| 67184-0531-1 | Gefitinib | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 7 |
| 67184-0531-2 | Gefitinib | 500 in 1 BOTTLE | TABLET, COATED | 500 | | 7 |
| 67184-0531-3 | Gefitinib | 3 in 1 CARTON | TABLET, COATED | 3 | | 7 |
| 67184-0531-3 | Gefitinib | 10 in 1 BLISTER PACK | TABLET, COATED | 10 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67184-0531 | GEFITINIB TABLET, COATED [QILU PHARMACEUTICAL CO., LTD.] | 7 | Current NDC, 4 package rows | 20230223_0afc12dd-12f8-4def-9027-f38412a862b9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 67184-0531-1 | 67184053101 | 30 TABLET, COATED in 1 BOTTLE (67184-0531-1) | | 2023-02-13 | No | No | Historical |
| 67184-0531-2 | 67184053102 | 500 TABLET, COATED in 1 BOTTLE (67184-0531-2) | | 2023-02-13 | No | No | Historical |
| 67184-0531-3 | 67184053103 | 3 BLISTER PACK in 1 CARTON (67184-0531-3) / 10 TABLET, COATED in 1 BLISTER PACK | 3 blister pack | 2023-02-13 | No | No | Historical |