fingolimod

Generic: fingolimod

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fingolimod
Generic Name fingolimod
Labeler aurobindo pharma limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fingolimod hydrochloride .5 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-952
Product ID 65862-952_067884b9-a619-48da-a4b2-225dce025421
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207983
Listing Expiration 2027-12-31
Marketing Start 2024-02-28

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 65862952
Hyphenated Format 65862-952

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 ANDA207983 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (65862-952-07) / 7 CAPSULE in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 CARTON (65862-952-28) / 7 CAPSULE in 1 BLISTER PACK
  • 30 CAPSULE in 1 BOTTLE (65862-952-30)
source: ndc

Packages (3)

65862-952-07 1 BLISTER PACK in 1 CARTON (65862-952-07) / 7 CAPSULE in 1 BLISTER PACK 65862-952-28 4 BLISTER PACK in 1 CARTON (65862-952-28) / 7 CAPSULE in 1 BLISTER PACK 65862-952-30 30 CAPSULE in 1 BOTTLE (65862-952-30)

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": "067884b9-a619-48da-a4b2-225dce025421", "openfda": {"unii": ["G926EC510T"], "rxcui": ["1012895"], "spl_set_id": ["d6301307-55c6-4b91-a505-ff93c865f859"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (65862-952-07)  / 7 CAPSULE in 1 BLISTER PACK", "package_ndc": "65862-952-07", "marketing_start_date": "20240228"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (65862-952-28)  / 7 CAPSULE in 1 BLISTER PACK", "package_ndc": "65862-952-28", "marketing_start_date": "20240228"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (65862-952-30)", "package_ndc": "65862-952-30", "marketing_start_date": "20240228"}], "brand_name": "FINGOLIMOD", "product_id": "65862-952_067884b9-a619-48da-a4b2-225dce025421", "dosage_form": "CAPSULE", "pharm_class": ["Sphingosine 1-Phosphate Receptor Modulators [MoA]", "Sphingosine 1-phosphate Receptor Modulator [EPC]"], "product_ndc": "65862-952", "generic_name": "FINGOLIMOD", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FINGOLIMOD", "active_ingredients": [{"name": "FINGOLIMOD HYDROCHLORIDE", "strength": ".5 mg/1"}], "application_number": "ANDA207983", "marketing_category": "ANDA", "marketing_start_date": "20240228", "listing_expiration_date": "20271231"}