NDC 0069-0227

Lorbrena

Lorlatinib

Lorbrena is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is Lorlatinib.

• Product ID: 0069-0227_4b051995-d812-4f93-87a1-6f53431bf7dc
• NDC: 0069-0227
• Product Type: Human Prescription Drug
• Proprietary Name: Lorbrena
• Generic Name: Lorlatinib
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-11-19
• Marketing Category: NDA / NDA
• Application Number: NDA210868
• Labeler Name: Pfizer Laboratories Div Pfizer Inc
• Substance Name: LORLATINIB
• Active Ingredient Strength: 25 mg/1
• Pharm Classes: Kinase Inhibitor [EPC],Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inducers [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0069-0227-01

30 TABLET, FILM COATED in 1 BOTTLE (0069-0227-01)

• Marketing Start Date: 2018-11-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0069-0227-01 [00069022701]

Lorbrena TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA210868
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-11-19

Drug Details

Active Ingredients

Ingredient	Strength
LORLATINIB	25 mg/1

OpenFDA Data

• SPL SET ID: 2b34d62d-e02a-4af3-bc0d-1571dd4ee76d
• Manufacturer:
  • Pfizer Laboratories Div Pfizer Inc
• UNII:
  • OSP71S83EU
• RxNorm Concept Unique ID - RxCUI:
  • 2103177
  • 2103175
  • 2103169
  • 2103179

Pharmacological Class

• Kinase Inhibitor [EPC]
• Kinase Inhibitors [MoA]
• Cytochrome P450 3A4 Inducers [MoA]

NDC Crossover Matching brand name "Lorbrena" or generic name "Lorlatinib"

NDC	Brand Name	Generic Name
0069-0227	Lorbrena	lorlatinib
0069-0231	Lorbrena	lorlatinib