cequa

Generic: cyclosporine

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cequa
Generic Name cyclosporine
Labeler sun pharmaceutical industries, inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC TOPICAL
Active Ingredients

cyclosporine .0009 g/mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-506
Product ID 47335-506_9db609da-42a0-42b1-87f5-020261a871ad
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210913
Listing Expiration 2026-12-31
Marketing Start 2018-08-15

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 47335506
Hyphenated Format 47335-506

Supplemental Identifiers

RxCUI
2055021 2055026
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 cequa (source: ndc)
Generic Name cyclosporine (source: ndc)
Application Number NDA210913 (source: ndc)
Routes
OPHTHALMIC TOPICAL
source: ndc

Resolved Composition

Strengths
  • .0009 g/mL
source: ndc
Packaging
  • 6 POUCH in 1 BOX (47335-506-96) / 10 VIAL, SINGLE-DOSE in 1 POUCH / .25 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

47335-506-96 6 POUCH in 1 BOX (47335-506-96) / 10 VIAL, SINGLE-DOSE in 1 POUCH / .25 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

cyclosporine (.0009 g/mL)

Linked Drug Pages (1)

CEQUA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC", "TOPICAL"], "spl_id": "9db609da-42a0-42b1-87f5-020261a871ad", "openfda": {"nui": ["N0000175457", "N0000175458", "N0000182141", "N0000185503"], "unii": ["83HN0GTJ6D"], "rxcui": ["2055021", "2055026"], "spl_set_id": ["48c3d8a3-4289-4b52-9189-58b48596095c"], "pharm_class_epc": ["Calcineurin Inhibitor Immunosuppressant [EPC]"], "pharm_class_moa": ["Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 POUCH in 1 BOX (47335-506-96)  / 10 VIAL, SINGLE-DOSE in 1 POUCH / .25 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "47335-506-96", "marketing_start_date": "20180815"}], "brand_name": "CEQUA", "product_id": "47335-506_9db609da-42a0-42b1-87f5-020261a871ad", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "47335-506", "generic_name": "cyclosporine", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CEQUA", "active_ingredients": [{"name": "CYCLOSPORINE", "strength": ".0009 g/mL"}], "application_number": "NDA210913", "marketing_category": "NDA", "marketing_start_date": "20180815", "listing_expiration_date": "20261231"}