fingolimod

Generic: fingolimod

Labeler: teva pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fingolimod
Generic Name fingolimod
Labeler teva pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fingolimod hydrochloride .5 mg/1

Manufacturer
Teva Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0480-7820
Product ID 0480-7820_26a5f3bb-96f1-4148-a6b2-a8f5ce83c0d1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208008
Listing Expiration 2027-12-31
Marketing Start 2024-02-14

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 04807820
Hyphenated Format 0480-7820

Supplemental Identifiers

RxCUI
1012895
UPC
0304807820565
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 ANDA208008 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (0480-7820-56)
source: ndc

Packages (1)

0480-7820-56 30 CAPSULE in 1 BOTTLE (0480-7820-56)

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": "26a5f3bb-96f1-4148-a6b2-a8f5ce83c0d1", "openfda": {"upc": ["0304807820565"], "unii": ["G926EC510T"], "rxcui": ["1012895"], "spl_set_id": ["d9aa1078-fd72-47ef-84b2-2e1ad17b12a2"], "manufacturer_name": ["Teva Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (0480-7820-56)", "package_ndc": "0480-7820-56", "marketing_start_date": "20240214"}], "brand_name": "Fingolimod", "product_id": "0480-7820_26a5f3bb-96f1-4148-a6b2-a8f5ce83c0d1", "dosage_form": "CAPSULE", "pharm_class": ["Sphingosine 1-Phosphate Receptor Modulators [MoA]", "Sphingosine 1-phosphate Receptor Modulator [EPC]"], "product_ndc": "0480-7820", "generic_name": "Fingolimod", "labeler_name": "Teva Pharmaceuticals, Inc.", "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": "20240214", "listing_expiration_date": "20271231"}