fingolimod

Generic: fingolimod

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fingolimod
Generic Name fingolimod
Labeler avkare
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fingolimod hydrochloride .5 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-048
Product ID 42291-048_484c1f9b-e013-9345-e063-6294a90a7d51
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208008
Listing Expiration 2027-12-31
Marketing Start 2024-02-15

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 42291048
Hyphenated Format 42291-048

Supplemental Identifiers

RxCUI
1012895
UPC
0342291048300
UNII
G926EC510T

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 ANDA208008 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (42291-048-30)
source: ndc

Packages (1)

42291-048-30 30 CAPSULE in 1 BOTTLE (42291-048-30)

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": "484c1f9b-e013-9345-e063-6294a90a7d51", "openfda": {"upc": ["0342291048300"], "unii": ["G926EC510T"], "rxcui": ["1012895"], "spl_set_id": ["1171df44-48b4-6ef2-e063-6294a90aa121"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (42291-048-30)", "package_ndc": "42291-048-30", "marketing_start_date": "20240215"}], "brand_name": "Fingolimod", "product_id": "42291-048_484c1f9b-e013-9345-e063-6294a90a7d51", "dosage_form": "CAPSULE", "pharm_class": ["Sphingosine 1-Phosphate Receptor Modulators [MoA]", "Sphingosine 1-phosphate Receptor Modulator [EPC]"], "product_ndc": "42291-048", "generic_name": "Fingolimod", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fingolimod", "active_ingredients": [{"name": "FINGOLIMOD HYDROCHLORIDE", "strength": ".5 mg/1"}], "application_number": "ANDA208008", "marketing_category": "ANDA", "marketing_start_date": "20240215", "listing_expiration_date": "20271231"}