fingolimod

Generic: fingolimod

Labeler: xlcare pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fingolimod
Generic Name fingolimod
Labeler xlcare pharmaceuticals inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fingolimod hydrochloride .5 mg/1

Manufacturer
XLCare Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 72865-257
Product ID 72865-257_1b506d53-7362-2b6a-e063-6394a90a0a69
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207933
Listing Expiration 2026-12-31
Marketing Start 2024-06-17

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 72865257
Hyphenated Format 72865-257

Supplemental Identifiers

RxCUI
1012895
UPC
0372865257302
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 ANDA207933 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (72865-257-30)
source: ndc

Packages (1)

72865-257-30 30 CAPSULE in 1 BOTTLE (72865-257-30)

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": "1b506d53-7362-2b6a-e063-6394a90a0a69", "openfda": {"upc": ["0372865257302"], "unii": ["G926EC510T"], "rxcui": ["1012895"], "spl_set_id": ["c5402dd1-c496-405d-9cae-07ccf184339c"], "manufacturer_name": ["XLCare Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (72865-257-30)", "package_ndc": "72865-257-30", "marketing_start_date": "20240617"}], "brand_name": "Fingolimod", "product_id": "72865-257_1b506d53-7362-2b6a-e063-6394a90a0a69", "dosage_form": "CAPSULE", "pharm_class": ["Sphingosine 1-Phosphate Receptor Modulators [MoA]", "Sphingosine 1-phosphate Receptor Modulator [EPC]"], "product_ndc": "72865-257", "generic_name": "Fingolimod", "labeler_name": "XLCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fingolimod", "active_ingredients": [{"name": "FINGOLIMOD HYDROCHLORIDE", "strength": ".5 mg/1"}], "application_number": "ANDA207933", "marketing_category": "ANDA", "marketing_start_date": "20240617", "listing_expiration_date": "20261231"}