TAGRISSO
- Product NDC
- 0310-1349
- 11-digit product format
- 003101349
- Labeler code
- 0310
- Product ID
- 0310-1349_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
- 40 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TAGRISSO
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OSIMERTINIB | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3C06JJ0Z2O |
| Rxcui | 1721565, 1721571, 1721581, 1721583 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0310-1349-30 | TAGRISSO | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 36 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OSIMERTINIB | ACTIVE INGREDIENT | 3C06JJ0Z2O | TAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] | 1 | |
| OSIMERTINIB | ACTIVE MOIETY | 3C06JJ0Z2O | TAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | TAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | TAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | TAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] | 1 | |
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | INACTIVE INGREDIENT | 2165RE0K14 | TAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | TAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] | 1 | |
| POLYETHYLENE GLYCOL 3350 | INACTIVE INGREDIENT | G2M7P15E5P | TAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] | 1 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | TAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] | 1 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | TAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | TAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0310-1349 | TAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] | 35 | Current NDC, Legacy NDC, 1 package rows | 20250228_5e81b4a7-b971-45e1-9c31-29cea8c87ce7.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 |
|---|
| 0310-1349-30 | 00310134930 | 30 TABLET, FILM COATED in 1 BOTTLE (0310-1349-30) | 2015-11-13 | 0000-00-00 | No | No | Current |