gilotrif

Generic: afatinib

Labeler: boehringer ingelheim pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name gilotrif
Generic Name afatinib
Labeler boehringer ingelheim pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

afatinib 40 mg/1

Manufacturer
Boehringer Ingelheim Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0597-0138
Product ID 0597-0138_3a365319-7ba8-4454-8239-7b0e7ff8a18e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA201292
Listing Expiration 2026-12-31
Marketing Start 2013-07-12

Pharmacologic Class

Established (EPC)
kinase inhibitor [epc]
Mechanism of Action
protein kinase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05970138
Hyphenated Format 0597-0138

Supplemental Identifiers

RxCUI
1430446 1430449 1430451 1430453 1430455 1430457
UNII
41UD74L59M
NUI
N0000175605 N0000175076

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 gilotrif (source: ndc)
Generic Name afatinib (source: ndc)
Application Number NDA201292 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0597-0138-30) / 30 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0597-0138-95) / 30 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (2)

0597-0138-30 1 BOTTLE in 1 CARTON (0597-0138-30) / 30 TABLET, FILM COATED in 1 BOTTLE 0597-0138-95 1 BOTTLE in 1 CARTON (0597-0138-95) / 30 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

afatinib (40 mg/1)

Linked Drug Pages (1)

Gilotrif ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3a365319-7ba8-4454-8239-7b0e7ff8a18e", "openfda": {"nui": ["N0000175605", "N0000175076"], "unii": ["41UD74L59M"], "rxcui": ["1430446", "1430449", "1430451", "1430453", "1430455", "1430457"], "spl_set_id": ["fd638e5e-8032-e7ca-0179-95e96ab5d387"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Protein Kinase Inhibitors [MoA]"], "manufacturer_name": ["Boehringer Ingelheim Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0597-0138-30)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0597-0138-30", "marketing_start_date": "20130808"}, {"sample": true, "description": "1 BOTTLE in 1 CARTON (0597-0138-95)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0597-0138-95", "marketing_end_date": "20270430", "marketing_start_date": "20130808"}], "brand_name": "Gilotrif", "product_id": "0597-0138_3a365319-7ba8-4454-8239-7b0e7ff8a18e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "0597-0138", "generic_name": "afatinib", "labeler_name": "Boehringer Ingelheim Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gilotrif", "active_ingredients": [{"name": "AFATINIB", "strength": "40 mg/1"}], "application_number": "NDA201292", "marketing_category": "NDA", "marketing_start_date": "20130712", "listing_expiration_date": "20261231"}