TAGRISSO
- Product NDC
- 0310-1251
- 11-digit product format
- 003101251
- Labeler code
- 0310
- Product ID
- 0310-1251_d703b5ed-4b1c-44fe-8005-ebe3d8f563e6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- osimertinib
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- AstraZeneca Pharmaceuticals LP
- Application
- NDA208065
- Marketing category
- NDA
- Marketing start
- 2015-11-13
- Substance
- OSIMERTINIB
- Active strength
- 80 mg/1
- Pharmacologic classes
- Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 3C06JJ0Z2O | OSIMERTINIB | 1421373-65-0 | OSIMERTINIB |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0310-1251-30 | 00310125130 | 30 TABLET, FILM COATED in 1 BOTTLE (0310-1251-30) | 2025-02-21 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| TAGRISSO | AstraZeneca Pharmaceuticals LP | AstraZeneca PLC | 2024-09-25 | HUMAN PRESCRIPTION DRUG LABEL | 36 |