cyclosporine

Generic: cyclosporine

Labeler: dr. reddy's laboratories inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclosporine
Generic Name cyclosporine
Labeler dr. reddy's laboratories inc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

cyclosporine 100 mg/1

Manufacturer
Dr. Reddy's Laboratories Inc

Identifiers & Regulatory

Product NDC 75907-048
Product ID 75907-048_d94fae26-e557-7f8f-1755-846c8f091506
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065044
Listing Expiration 2026-12-31
Marketing Start 2024-07-01

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 75907048
Hyphenated Format 75907-048

Supplemental Identifiers

RxCUI
241834 835894
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 ANDA065044 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 BOX (75907-048-30) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (75907-048-81)
source: ndc

Packages (1)

75907-048-30 30 BLISTER PACK in 1 BOX (75907-048-30) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (75907-048-81)

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": "d94fae26-e557-7f8f-1755-846c8f091506", "openfda": {"nui": ["N0000175457", "N0000175458", "N0000182141", "N0000185503"], "unii": ["83HN0GTJ6D"], "rxcui": ["241834", "835894"], "spl_set_id": ["64ec430a-e930-145c-e766-13fb49b64644"], "pharm_class_epc": ["Calcineurin Inhibitor Immunosuppressant [EPC]"], "pharm_class_moa": ["Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["Dr. Reddy's Laboratories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 BOX (75907-048-30)  / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (75907-048-81)", "package_ndc": "75907-048-30", "marketing_start_date": "20240701"}], "brand_name": "Cyclosporine", "product_id": "75907-048_d94fae26-e557-7f8f-1755-846c8f091506", "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": "75907-048", "generic_name": "Cyclosporine", "labeler_name": "Dr. Reddy's Laboratories Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclosporine", "active_ingredients": [{"name": "CYCLOSPORINE", "strength": "100 mg/1"}], "application_number": "ANDA065044", "marketing_category": "ANDA", "marketing_start_date": "20240701", "listing_expiration_date": "20261231"}