fingolimod

Generic: fingolimod

Labeler: quallent pharmaceuticals health llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fingolimod
Generic Name fingolimod
Labeler quallent pharmaceuticals health llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fingolimod hydrochloride .5 mg/1

Manufacturer
Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-143
Product ID 82009-143_c10504a7-d1e3-b3d2-2b35-43f1e602d8c9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207979
Listing Expiration 2026-12-31
Marketing Start 2024-03-28

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 82009143
Hyphenated Format 82009-143

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 ANDA207979 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (82009-143-30)
source: ndc

Packages (1)

82009-143-30 30 CAPSULE in 1 BOTTLE (82009-143-30)

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": "c10504a7-d1e3-b3d2-2b35-43f1e602d8c9", "openfda": {"unii": ["G926EC510T"], "rxcui": ["1012895"], "spl_set_id": ["5434bd4a-2610-0e17-4f14-513ff1cbb822"], "manufacturer_name": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (82009-143-30)", "package_ndc": "82009-143-30", "marketing_start_date": "20240328"}], "brand_name": "FINGOLIMOD", "product_id": "82009-143_c10504a7-d1e3-b3d2-2b35-43f1e602d8c9", "dosage_form": "CAPSULE", "pharm_class": ["Sphingosine 1-Phosphate Receptor Modulators [MoA]", "Sphingosine 1-phosphate Receptor Modulator [EPC]"], "product_ndc": "82009-143", "generic_name": "FINGOLIMOD", "labeler_name": "Quallent Pharmaceuticals Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FINGOLIMOD", "active_ingredients": [{"name": "FINGOLIMOD HYDROCHLORIDE", "strength": ".5 mg/1"}], "application_number": "ANDA207979", "marketing_category": "ANDA", "marketing_start_date": "20240328", "listing_expiration_date": "20261231"}