fingolimod

Generic: fingolimod

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fingolimod
Generic Name fingolimod
Labeler zydus lifesciences limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fingolimod hydrochloride .5 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1603
Product ID 70771-1603_423dd0fd-c654-4de1-b535-947cd795758b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207994
Listing Expiration 2026-12-31
Marketing Start 2022-10-11

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 707711603
Hyphenated Format 70771-1603

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 ANDA207994 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (70771-1603-1)
  • 30 CAPSULE in 1 BOTTLE (70771-1603-3)
  • 1 BLISTER PACK in 1 CARTON (70771-1603-7) / 7 CAPSULE in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 CARTON (70771-1603-8) / 7 CAPSULE in 1 BLISTER PACK
  • 90 CAPSULE in 1 BOTTLE (70771-1603-9)
source: ndc

Packages (5)

70771-1603-1 100 CAPSULE in 1 BOTTLE (70771-1603-1) 70771-1603-3 30 CAPSULE in 1 BOTTLE (70771-1603-3) 70771-1603-7 1 BLISTER PACK in 1 CARTON (70771-1603-7) / 7 CAPSULE in 1 BLISTER PACK 70771-1603-8 4 BLISTER PACK in 1 CARTON (70771-1603-8) / 7 CAPSULE in 1 BLISTER PACK 70771-1603-9 90 CAPSULE in 1 BOTTLE (70771-1603-9)

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": "423dd0fd-c654-4de1-b535-947cd795758b", "openfda": {"unii": ["G926EC510T"], "rxcui": ["1012895"], "spl_set_id": ["5a0319b4-4bc6-4564-9687-9cfd5c1b23a8"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (70771-1603-1)", "package_ndc": "70771-1603-1", "marketing_start_date": "20221011"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (70771-1603-3)", "package_ndc": "70771-1603-3", "marketing_start_date": "20221011"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (70771-1603-7)  / 7 CAPSULE in 1 BLISTER PACK", "package_ndc": "70771-1603-7", "marketing_start_date": "20221011"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (70771-1603-8)  / 7 CAPSULE in 1 BLISTER PACK", "package_ndc": "70771-1603-8", "marketing_start_date": "20221011"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (70771-1603-9)", "package_ndc": "70771-1603-9", "marketing_start_date": "20221011"}], "brand_name": "Fingolimod", "product_id": "70771-1603_423dd0fd-c654-4de1-b535-947cd795758b", "dosage_form": "CAPSULE", "pharm_class": ["Sphingosine 1-Phosphate Receptor Modulators [MoA]", "Sphingosine 1-phosphate Receptor Modulator [EPC]"], "product_ndc": "70771-1603", "generic_name": "Fingolimod", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fingolimod", "active_ingredients": [{"name": "FINGOLIMOD HYDROCHLORIDE", "strength": ".5 mg/1"}], "application_number": "ANDA207994", "marketing_category": "ANDA", "marketing_start_date": "20221011", "listing_expiration_date": "20261231"}