fingolimod

Generic: fingolimod hcl

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fingolimod
Generic Name fingolimod hcl
Labeler rising pharma holdings, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fingolimod hydrochloride .5 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-449
Product ID 64980-449_2622c15a-3781-3016-e063-6294a90a84d5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207939
Listing Expiration 2026-12-31
Marketing Start 2021-11-10

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 64980449
Hyphenated Format 64980-449

Supplemental Identifiers

RxCUI
1012895
UPC
0364980449038
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 hcl (source: ndc)
Application Number ANDA207939 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (64980-449-03)
source: ndc

Packages (1)

64980-449-03 30 CAPSULE in 1 BOTTLE (64980-449-03)

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": "2622c15a-3781-3016-e063-6294a90a84d5", "openfda": {"upc": ["0364980449038"], "unii": ["G926EC510T"], "rxcui": ["1012895"], "spl_set_id": ["99e7daf4-ea90-5e47-e053-2a95a90ac1b7"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (64980-449-03)", "package_ndc": "64980-449-03", "marketing_start_date": "20230904"}], "brand_name": "fingolimod", "product_id": "64980-449_2622c15a-3781-3016-e063-6294a90a84d5", "dosage_form": "CAPSULE", "pharm_class": ["Sphingosine 1-Phosphate Receptor Modulators [MoA]", "Sphingosine 1-phosphate Receptor Modulator [EPC]"], "product_ndc": "64980-449", "generic_name": "Fingolimod hcl", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "fingolimod", "active_ingredients": [{"name": "FINGOLIMOD HYDROCHLORIDE", "strength": ".5 mg/1"}], "application_number": "ANDA207939", "marketing_category": "ANDA", "marketing_start_date": "20211110", "listing_expiration_date": "20261231"}