Package 68382-912-01

Brand: fingolimod

Generic: fingolimod
NDC Package

Package Facts

Identity

Package NDC 68382-912-01
Digits Only 6838291201
Product NDC 68382-912
Description

100 CAPSULE in 1 BOTTLE (68382-912-01)

Marketing

Marketing Status
Marketed Since 2022-10-11
Brand fingolimod
Generic fingolimod
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "37d21196-e2e4-45ce-a16c-f8e8693c94de", "openfda": {"upc": ["0368382912060"], "unii": ["G926EC510T"], "rxcui": ["1012895"], "spl_set_id": ["e738dbd9-f4cc-49a0-98ce-73dd0c3ff3b3"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (68382-912-01)", "package_ndc": "68382-912-01", "marketing_start_date": "20221011"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (68382-912-06)", "package_ndc": "68382-912-06", "marketing_start_date": "20221011"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (68382-912-16)", "package_ndc": "68382-912-16", "marketing_start_date": "20221011"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (68382-912-69)  / 7 CAPSULE in 1 BLISTER PACK", "package_ndc": "68382-912-69", "marketing_start_date": "20221011"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (68382-912-70)  / 7 CAPSULE in 1 BLISTER PACK", "package_ndc": "68382-912-70", "marketing_start_date": "20221011"}], "brand_name": "Fingolimod", "product_id": "68382-912_37d21196-e2e4-45ce-a16c-f8e8693c94de", "dosage_form": "CAPSULE", "pharm_class": ["Sphingosine 1-Phosphate Receptor Modulators [MoA]", "Sphingosine 1-phosphate Receptor Modulator [EPC]"], "product_ndc": "68382-912", "generic_name": "Fingolimod", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fingolimod", "active_ingredients": [{"name": "FINGOLIMOD HYDROCHLORIDE", "strength": ".5 mg/1"}], "application_number": "ANDA207994", "marketing_category": "ANDA", "marketing_start_date": "20221011", "listing_expiration_date": "20261231"}