fingolimod

Generic: fingolimod

Labeler: biocon pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fingolimod
Generic Name fingolimod
Labeler biocon pharma inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fingolimod hydrochloride .5 mg/1

Manufacturer
Biocon Pharma Inc.

Identifiers & Regulatory

Product NDC 70377-019
Product ID 70377-019_15cd90eb-b3a8-6725-cda0-c3ab23054184
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 70377019
Hyphenated Format 70377-019

Supplemental Identifiers

RxCUI
1012895
UPC
0370377019210 0370377019111
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 (70377-019-11)
  • 28 CAPSULE in 1 CARTON (70377-019-21)
source: ndc

Packages (2)

70377-019-11 30 CAPSULE in 1 BOTTLE (70377-019-11) 70377-019-21 28 CAPSULE in 1 CARTON (70377-019-21)

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": "15cd90eb-b3a8-6725-cda0-c3ab23054184", "openfda": {"upc": ["0370377019210", "0370377019111"], "unii": ["G926EC510T"], "rxcui": ["1012895"], "spl_set_id": ["550a5fa3-94a4-0b55-9cb5-c0178acfe319"], "manufacturer_name": ["Biocon Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (70377-019-11)", "package_ndc": "70377-019-11", "marketing_start_date": "20240328"}, {"sample": false, "description": "28 CAPSULE in 1 CARTON (70377-019-21)", "package_ndc": "70377-019-21", "marketing_start_date": "20240328"}], "brand_name": "FINGOLIMOD", "product_id": "70377-019_15cd90eb-b3a8-6725-cda0-c3ab23054184", "dosage_form": "CAPSULE", "pharm_class": ["Sphingosine 1-Phosphate Receptor Modulators [MoA]", "Sphingosine 1-phosphate Receptor Modulator [EPC]"], "product_ndc": "70377-019", "generic_name": "FINGOLIMOD", "labeler_name": "Biocon Pharma Inc.", "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"}