NDC 0597-0138

Gilotrif

Afatinib

Gilotrif is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.. The primary component is Afatinib.

• Product ID: 0597-0138_256c019d-6658-43f0-8ec5-2dee75f0e92d
• NDC: 0597-0138
• Product Type: Human Prescription Drug
• Proprietary Name: Gilotrif
• Generic Name: Afatinib
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2013-07-12
• Marketing Category: NDA / NDA
• Application Number: NDA201292
• Labeler Name: Boehringer Ingelheim Pharmaceuticals, Inc.
• Substance Name: AFATINIB
• Active Ingredient Strength: 40 mg/1
• Pharm Classes: Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0597-0138-30

1 BOTTLE in 1 CARTON (0597-0138-30) > 30 TABLET, FILM COATED in 1 BOTTLE

• Marketing Start Date: 2013-08-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0597-0138-30 [00597013830]

Gilotrif TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA201292
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-08-08

NDC 0597-0138-95 [00597013895]

Gilotrif TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA201292
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-08-08

Drug Details

Active Ingredients

Ingredient	Strength
AFATINIB	40 mg/1

OpenFDA Data

• SPL SET ID: fd638e5e-8032-e7ca-0179-95e96ab5d387
• Manufacturer:
  • Boehringer Ingelheim Pharmaceuticals, Inc.
• UNII:
  • 41UD74L59M
• RxNorm Concept Unique ID - RxCUI:
  • 1430446
  • 1430449
  • 1430457
  • 1430455
  • 1430453
  • 1430451

Pharmacological Class

• Kinase Inhibitor [EPC]
• Protein Kinase Inhibitors [MoA]

NDC Crossover Matching brand name "Gilotrif" or generic name "Afatinib"

NDC	Brand Name	Generic Name
0597-0137	Gilotrif	afatinib
0597-0138	Gilotrif	afatinib
0597-0141	Gilotrif	afatinib