Gefitinib
- Product NDC
- 69339-168
- 11-digit product format
- 693390168
- Labeler code
- 69339
- Product ID
- 69339-168_5a5b1155-767f-4e57-bd89-c67c80b40972
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gefitinib
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Natco Pharma USA LLC
- Application
- ANDA212827
- Marketing category
- ANDA
- Marketing start
- 2023-06-05
- Substance
- GEFITINIB
- Active strength
- 250 mg/1
- Pharmacologic classes
- Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Gefitinib
- Listing expiration
- 2027-12-31
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 |
|---|
| 69339-168-03 | Gefitinib | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69339-168 | GEFITINIB TABLET, FILM COATED [NATCO PHARMA USA LLC] | 2 | Current NDC, 1 package rows | 20230928_1a3c0ce7-06a1-4e04-9106-14ddb2a866a5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 69339-168-03 | 69339016803 | 30 TABLET, FILM COATED in 1 BOTTLE (69339-168-03) | 2023-06-05 | No | No | Historical |