gengraf

Generic: cyclosporine

Labeler: abbvie inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gengraf
Generic Name cyclosporine
Labeler abbvie inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

cyclosporine 100 mg/1

Manufacturer
AbbVie Inc.

Identifiers & Regulatory

Product NDC 0074-3109
Product ID 0074-3109_d8bf4cee-43f0-4750-8f27-c5b1d28edf4c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065003
Listing Expiration 2026-12-31
Marketing Start 2015-11-01

Pharmacologic Class

Established (EPC)
calcineurin inhibitor immunosuppressant [epc]
Mechanism of Action
calcineurin inhibitors [moa] cytochrome p450 3a4 inhibitors [moa] p-glycoprotein inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00743109
Hyphenated Format 0074-3109

Supplemental Identifiers

RxCUI
241834 835835 835894 835896 835925 1797521
UNII
83HN0GTJ6D
NUI
N0000175457 N0000175458 N0000182141 N0000185503

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 gengraf (source: ndc)
Generic Name cyclosporine (source: ndc)
Application Number ANDA065003 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 5 BLISTER PACK in 1 CARTON (0074-3109-32) / 6 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (1)

0074-3109-32 5 BLISTER PACK in 1 CARTON (0074-3109-32) / 6 CAPSULE in 1 BLISTER PACK

Ingredients (1)

cyclosporine (100 mg/1)

Linked Drug Pages (1)

Gengraf ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d8bf4cee-43f0-4750-8f27-c5b1d28edf4c", "openfda": {"nui": ["N0000175457", "N0000175458", "N0000182141", "N0000185503"], "unii": ["83HN0GTJ6D"], "rxcui": ["241834", "835835", "835894", "835896", "835925", "1797521"], "spl_set_id": ["e896cbfe-4745-4088-82a3-8dc10b75c41f"], "pharm_class_epc": ["Calcineurin Inhibitor Immunosuppressant [EPC]"], "pharm_class_moa": ["Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["AbbVie Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 BLISTER PACK in 1 CARTON (0074-3109-32)  / 6 CAPSULE in 1 BLISTER PACK", "package_ndc": "0074-3109-32", "marketing_start_date": "20151101"}], "brand_name": "Gengraf", "product_id": "0074-3109_d8bf4cee-43f0-4750-8f27-c5b1d28edf4c", "dosage_form": "CAPSULE", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "0074-3109", "generic_name": "Cyclosporine", "labeler_name": "AbbVie Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gengraf", "active_ingredients": [{"name": "CYCLOSPORINE", "strength": "100 mg/1"}], "application_number": "ANDA065003", "marketing_category": "ANDA", "marketing_start_date": "20151101", "listing_expiration_date": "20261231"}