cyclosporine

Generic: cyclosporine

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclosporine
Generic Name cyclosporine
Labeler american health packaging
Dosage Form CAPSULE, GELATIN COATED
Routes
ORAL
Active Ingredients

cyclosporine 100 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 68084-921
Product ID 68084-921_1857b1ea-c3f7-696a-e063-6394a90ad6eb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065040
Listing Expiration 2026-12-31
Marketing Start 2015-11-03

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 68084921
Hyphenated Format 68084-921

Supplemental Identifiers

RxCUI
197553 328160
UNII
83HN0GTJ6D
NUI
N0000175457 N0000175458 N0000182141 N0000185503

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 ANDA065040 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-921-25) / 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (68084-921-95)
source: ndc

Packages (1)

68084-921-25 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-921-25) / 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (68084-921-95)

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": "1857b1ea-c3f7-696a-e063-6394a90ad6eb", "openfda": {"nui": ["N0000175457", "N0000175458", "N0000182141", "N0000185503"], "unii": ["83HN0GTJ6D"], "rxcui": ["197553", "328160"], "spl_set_id": ["a8e29b54-e4ab-4bb9-ab6c-e4414a3f025b"], "pharm_class_epc": ["Calcineurin Inhibitor Immunosuppressant [EPC]"], "pharm_class_moa": ["Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-921-25)  / 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (68084-921-95)", "package_ndc": "68084-921-25", "marketing_start_date": "20151103"}], "brand_name": "Cyclosporine", "product_id": "68084-921_1857b1ea-c3f7-696a-e063-6394a90ad6eb", "dosage_form": "CAPSULE, GELATIN COATED", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "68084-921", "generic_name": "Cyclosporine", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclosporine", "active_ingredients": [{"name": "CYCLOSPORINE", "strength": "100 mg/1"}], "application_number": "ANDA065040", "marketing_category": "ANDA", "marketing_start_date": "20151103", "listing_expiration_date": "20261231"}