cyclosporine

Generic: cyclosporine

Labeler: saptalis pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclosporine
Generic Name cyclosporine
Labeler saptalis pharmaceuticals, llc
Dosage Form EMULSION
Routes
OPHTHALMIC
Active Ingredients

cyclosporine .5 mg/mL

Manufacturer
Saptalis Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 71656-012
Product ID 71656-012_458a84bc-12a1-5159-e063-6394a90ac45c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211943
Listing Expiration 2026-12-31
Marketing Start 2025-12-12

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 71656012
Hyphenated Format 71656-012

Supplemental Identifiers

RxCUI
2572292
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 ANDA211943 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 6 POUCH in 1 CARTON (71656-012-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE
  • 12 POUCH in 1 CARTON (71656-012-60) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

71656-012-30 6 POUCH in 1 CARTON (71656-012-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE 71656-012-60 12 POUCH in 1 CARTON (71656-012-60) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

cyclosporine (.5 mg/mL)

Linked Drug Pages (1)

CYCLOSPORINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "458a84bc-12a1-5159-e063-6394a90ac45c", "openfda": {"nui": ["N0000175457", "N0000175458", "N0000182141", "N0000185503"], "unii": ["83HN0GTJ6D"], "rxcui": ["2572292"], "spl_set_id": ["ff4dc2fc-667a-489a-b798-8d11cddfe716"], "pharm_class_epc": ["Calcineurin Inhibitor Immunosuppressant [EPC]"], "pharm_class_moa": ["Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["Saptalis Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 POUCH in 1 CARTON (71656-012-30)  / 5 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "71656-012-30", "marketing_start_date": "20251212"}, {"sample": false, "description": "12 POUCH in 1 CARTON (71656-012-60)  / 5 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "71656-012-60", "marketing_start_date": "20251212"}], "brand_name": "CYCLOSPORINE", "product_id": "71656-012_458a84bc-12a1-5159-e063-6394a90ac45c", "dosage_form": "EMULSION", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "71656-012", "generic_name": "CYCLOSPORINE", "labeler_name": "Saptalis Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CYCLOSPORINE", "active_ingredients": [{"name": "CYCLOSPORINE", "strength": ".5 mg/mL"}], "application_number": "ANDA211943", "marketing_category": "ANDA", "marketing_start_date": "20251212", "listing_expiration_date": "20261231"}