cyclosporine

Generic: cyclosporine

Labeler: heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclosporine
Generic Name cyclosporine
Labeler heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

cyclosporine 100 mg/1

Manufacturer
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 23155-839
Product ID 23155-839_15185077-eec3-40ca-a492-f500a05a045b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216046
Listing Expiration 2026-12-31
Marketing Start 2022-11-30

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 23155839
Hyphenated Format 23155-839

Supplemental Identifiers

RxCUI
241834 835894 835925
UPC
0323155839302
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 cyclosporine (source: ndc)
Generic Name cyclosporine (source: ndc)
Application Number ANDA216046 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 5 BLISTER PACK in 1 CARTON (23155-839-30) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (23155-839-11)
source: ndc

Packages (1)

23155-839-30 5 BLISTER PACK in 1 CARTON (23155-839-30) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (23155-839-11)

Ingredients (1)

cyclosporine (100 mg/1)

Linked Drug Pages (1)

CYCLOSPORINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "15185077-eec3-40ca-a492-f500a05a045b", "openfda": {"nui": ["N0000175457", "N0000175458", "N0000182141", "N0000185503"], "upc": ["0323155839302"], "unii": ["83HN0GTJ6D"], "rxcui": ["241834", "835894", "835925"], "spl_set_id": ["1952d4c7-a40e-4924-b669-c41400774cb9"], "pharm_class_epc": ["Calcineurin Inhibitor Immunosuppressant [EPC]"], "pharm_class_moa": ["Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 BLISTER PACK in 1 CARTON (23155-839-30)  / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (23155-839-11)", "package_ndc": "23155-839-30", "marketing_start_date": "20221130"}], "brand_name": "CYCLOSPORINE", "product_id": "23155-839_15185077-eec3-40ca-a492-f500a05a045b", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "23155-839", "generic_name": "CYCLOSPORINE", "labeler_name": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CYCLOSPORINE", "active_ingredients": [{"name": "CYCLOSPORINE", "strength": "100 mg/1"}], "application_number": "ANDA216046", "marketing_category": "ANDA", "marketing_start_date": "20221130", "listing_expiration_date": "20261231"}