fingolimod

Generic: fingolimod

Labeler: solco healthcare us, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fingolimod
Generic Name fingolimod
Labeler solco healthcare us, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fingolimod .5 mg/1

Manufacturer
Solco Healthcare US, LLC

Identifiers & Regulatory

Product NDC 43547-003
Product ID 43547-003_8a52d7dc-58d1-4dec-bfbd-5424ec30b984
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208003
Listing Expiration 2026-12-31
Marketing Start 2020-02-17

Pharmacologic Class

Established (EPC)
sphingosine 1-phosphate receptor modulator [epc]
Mechanism of Action
sphingosine 1-phosphate receptor modulators [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43547003
Hyphenated Format 43547-003

Supplemental Identifiers

RxCUI
1012895
UNII
3QN8BYN5QF
NUI
N0000181815 N0000181816

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 ANDA208003 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (43547-003-03)
  • 90 CAPSULE in 1 BOTTLE (43547-003-09)
source: ndc

Packages (2)

43547-003-03 30 CAPSULE in 1 BOTTLE (43547-003-03) 43547-003-09 90 CAPSULE in 1 BOTTLE (43547-003-09)

Ingredients (1)

fingolimod (.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": "8a52d7dc-58d1-4dec-bfbd-5424ec30b984", "openfda": {"nui": ["N0000181815", "N0000181816"], "unii": ["3QN8BYN5QF"], "rxcui": ["1012895"], "spl_set_id": ["6c0faf2b-21fb-4830-bb78-5f2dbceb2c82"], "pharm_class_epc": ["Sphingosine 1-phosphate Receptor Modulator [EPC]"], "pharm_class_moa": ["Sphingosine 1-Phosphate Receptor Modulators [MoA]"], "manufacturer_name": ["Solco Healthcare US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (43547-003-03)", "package_ndc": "43547-003-03", "marketing_start_date": "20211026"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (43547-003-09)", "package_ndc": "43547-003-09", "marketing_start_date": "20211026"}], "brand_name": "FINGOLIMOD", "product_id": "43547-003_8a52d7dc-58d1-4dec-bfbd-5424ec30b984", "dosage_form": "CAPSULE", "pharm_class": ["Sphingosine 1-Phosphate Receptor Modulators [MoA]", "Sphingosine 1-phosphate Receptor Modulator [EPC]"], "product_ndc": "43547-003", "generic_name": "fingolimod", "labeler_name": "Solco Healthcare US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FINGOLIMOD", "active_ingredients": [{"name": "FINGOLIMOD", "strength": ".5 mg/1"}], "application_number": "ANDA208003", "marketing_category": "ANDA", "marketing_start_date": "20200217", "listing_expiration_date": "20261231"}