fingolimod

Generic: fingolimod

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

Drug Facts

Product Profile

Brand Name fingolimod
Generic Name fingolimod
Labeler sun pharmaceutical industries, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fingolimod hydrochloride .5 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 62756-064
Product ID 62756-064_a0abec7c-e7a2-4bbf-936a-370e0eff4e9f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208014
Listing Expiration 2026-12-31
Marketing Start 2022-10-25

Pharmacologic Class

Classes
sphingosine 1-phosphate receptor modulators [moa] sphingosine 1-phosphate receptor modulator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62756064
Hyphenated Format 62756-064

Supplemental Identifiers

RxCUI
1012895
UPC
0362756064836
UNII
G926EC510T

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 fingolimod (source: ndc)
Generic Name fingolimod (source: ndc)
Application Number ANDA208014 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (62756-064-59) / 7 CAPSULE in 1 BLISTER PACK
  • 90 CAPSULE in 1 BOTTLE (62756-064-81)
  • 30 CAPSULE in 1 BOTTLE (62756-064-83)
  • 2 BLISTER PACK in 1 CARTON (62756-064-96) / 14 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (4)

62756-064-59 1 BLISTER PACK in 1 CARTON (62756-064-59) / 7 CAPSULE in 1 BLISTER PACK 62756-064-81 90 CAPSULE in 1 BOTTLE (62756-064-81) 62756-064-83 30 CAPSULE in 1 BOTTLE (62756-064-83) 62756-064-96 2 BLISTER PACK in 1 CARTON (62756-064-96) / 14 CAPSULE in 1 BLISTER PACK

Ingredients (1)

fingolimod hydrochloride (.5 mg/1)

Linked Drug Pages (1)

Fingolimod ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a0abec7c-e7a2-4bbf-936a-370e0eff4e9f", "openfda": {"upc": ["0362756064836"], "unii": ["G926EC510T"], "rxcui": ["1012895"], "spl_set_id": ["b228dac8-b07d-424d-b23b-a03573517c54"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (62756-064-59)  / 7 CAPSULE in 1 BLISTER PACK", "package_ndc": "62756-064-59", "marketing_start_date": "20221025"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (62756-064-81)", "package_ndc": "62756-064-81", "marketing_start_date": "20221025"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (62756-064-83)", "package_ndc": "62756-064-83", "marketing_start_date": "20221025"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (62756-064-96)  / 14 CAPSULE in 1 BLISTER PACK", "package_ndc": "62756-064-96", "marketing_start_date": "20221025"}], "brand_name": "Fingolimod", "product_id": "62756-064_a0abec7c-e7a2-4bbf-936a-370e0eff4e9f", "dosage_form": "CAPSULE", "pharm_class": ["Sphingosine 1-Phosphate Receptor Modulators [MoA]", "Sphingosine 1-phosphate Receptor Modulator [EPC]"], "product_ndc": "62756-064", "generic_name": "Fingolimod", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fingolimod", "active_ingredients": [{"name": "FINGOLIMOD HYDROCHLORIDE", "strength": ".5 mg/1"}], "application_number": "ANDA208014", "marketing_category": "ANDA", "marketing_start_date": "20221025", "listing_expiration_date": "20261231"}