NDC 0310-1350

TAGRISSO

Osimertinib

TAGRISSO is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Osimertinib.

• Product ID: 0310-1350_1c8a97f0-4187-4e77-9b9b-d7a1d8ec6af0
• NDC: 0310-1350
• Product Type: Human Prescription Drug
• Proprietary Name: TAGRISSO
• Generic Name: Osimertinib
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2015-11-13
• Marketing Category: NDA / NDA
• Application Number: NDA208065
• Labeler Name: AstraZeneca Pharmaceuticals LP
• Substance Name: OSIMERTINIB
• Active Ingredient Strength: 80 mg/1
• Pharm 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: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0310-1350-30

30 TABLET, FILM COATED in 1 BOTTLE (0310-1350-30)

• Marketing Start Date: 2015-11-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0310-1350-30 [00310135030]

TAGRISSO TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA208065
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-11-13

Drug Details

Active Ingredients

Ingredient	Strength
OSIMERTINIB	80 1/1

OpenFDA Data

• SPL SET ID: 5e81b4a7-b971-45e1-9c31-29cea8c87ce7
• Manufacturer:
  • AstraZeneca Pharmaceuticals LP
• UNII:
  • 3C06JJ0Z2O
• RxNorm Concept Unique ID - RxCUI:
  • 1721583
  • 1721581
  • 1721565
  • 1721571

Pharmacological Class

• Kinase Inhibitor [EPC]
• Kinase Inhibitors [MoA]
• Cytochrome P450 3A Inhibitors [MoA]
• Cytochrome P450 3A4 Inducers [MoA]
• Cytochrome P450 1A2 Inducers [MoA]
• Breast Cancer Resistance Protein Inhibitors [MoA]

NDC Crossover Matching brand name "TAGRISSO" or generic name "Osimertinib"

NDC	Brand Name	Generic Name
0310-1349	TAGRISSO	osimertinib
0310-1350	TAGRISSO	osimertinib