fingolimod

Generic: fingolimod

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fingolimod
Generic Name fingolimod
Labeler apotex corp.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fingolimod hydrochloride .5 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-4332
Product ID 60505-4332_308bc432-976f-c1eb-e2fb-bd2ec51f22cf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207993
Listing Expiration 2026-12-31
Marketing Start 2022-10-18

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 605054332
Hyphenated Format 60505-4332

Supplemental Identifiers

RxCUI
1012895
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 ANDA207993 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (60505-4332-3)
source: ndc

Packages (1)

60505-4332-3 30 CAPSULE in 1 BOTTLE (60505-4332-3)

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": "308bc432-976f-c1eb-e2fb-bd2ec51f22cf", "openfda": {"unii": ["G926EC510T"], "rxcui": ["1012895"], "spl_set_id": ["a545c6fc-7006-52c2-f476-34e9801ac04f"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (60505-4332-3)", "package_ndc": "60505-4332-3", "marketing_start_date": "20221018"}], "brand_name": "Fingolimod", "product_id": "60505-4332_308bc432-976f-c1eb-e2fb-bd2ec51f22cf", "dosage_form": "CAPSULE", "pharm_class": ["Sphingosine 1-Phosphate Receptor Modulators [MoA]", "Sphingosine 1-phosphate Receptor Modulator [EPC]"], "product_ndc": "60505-4332", "generic_name": "Fingolimod", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fingolimod", "active_ingredients": [{"name": "FINGOLIMOD HYDROCHLORIDE", "strength": ".5 mg/1"}], "application_number": "ANDA207993", "marketing_category": "ANDA", "marketing_start_date": "20221018", "listing_expiration_date": "20261231"}