tagrisso

Generic: osimertinib

Labeler: astrazeneca pharmaceuticals lp
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tagrisso
Generic Name osimertinib
Labeler astrazeneca pharmaceuticals lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

osimertinib 80 mg/1

Manufacturer
AstraZeneca Pharmaceuticals LP

Identifiers & Regulatory

Product NDC 0310-1251
Product ID 0310-1251_b4ae37b4-12de-4824-9b06-833e0f18fd38
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208065
Listing Expiration 2026-12-31
Marketing Start 2015-11-13

Pharmacologic Class

Established (EPC)
kinase inhibitor [epc]
Mechanism of Action
kinase inhibitors [moa] cytochrome p450 3a inhibitors [moa] cytochrome p450 3a4 inducers [moa] cytochrome p450 1a2 inducers [moa] breast cancer resistance protein inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03101251
Hyphenated Format 0310-1251

Supplemental Identifiers

RxCUI
1721565 1721571 1721581 1721583
UNII
3C06JJ0Z2O
NUI
N0000175605 N0000175082 N0000190114 N0000185506 N0000191266 N0000190113

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tagrisso (source: ndc)
Generic Name osimertinib (source: ndc)
Application Number NDA208065 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (0310-1251-30)
source: ndc

Packages (1)

0310-1251-30 30 TABLET, FILM COATED in 1 BOTTLE (0310-1251-30)

Ingredients (1)

osimertinib (80 mg/1)

Linked Drug Pages (1)

TAGRISSO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b4ae37b4-12de-4824-9b06-833e0f18fd38", "openfda": {"nui": ["N0000175605", "N0000175082", "N0000190114", "N0000185506", "N0000191266", "N0000190113"], "unii": ["3C06JJ0Z2O"], "rxcui": ["1721565", "1721571", "1721581", "1721583"], "spl_set_id": ["5e81b4a7-b971-45e1-9c31-29cea8c87ce7"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Kinase Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Cytochrome P450 1A2 Inducers [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]"], "manufacturer_name": ["AstraZeneca Pharmaceuticals LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0310-1251-30)", "package_ndc": "0310-1251-30", "marketing_start_date": "20250221"}], "brand_name": "TAGRISSO", "product_id": "0310-1251_b4ae37b4-12de-4824-9b06-833e0f18fd38", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["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]"], "product_ndc": "0310-1251", "generic_name": "osimertinib", "labeler_name": "AstraZeneca Pharmaceuticals LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TAGRISSO", "active_ingredients": [{"name": "OSIMERTINIB", "strength": "80 mg/1"}], "application_number": "NDA208065", "marketing_category": "NDA", "marketing_start_date": "20151113", "listing_expiration_date": "20261231"}