fingolimod

Generic: fingolimod

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

Drug Facts

Product Profile

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

fingolimod hydrochloride .5 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-166
Product ID 68462-166_6640fd85-57d1-4ec5-b555-8dce3037d409
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207985
Listing Expiration 2027-12-31
Marketing Start 2022-09-28

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 68462166
Hyphenated Format 68462-166

Supplemental Identifiers

RxCUI
1012895
UPC
0368462166307
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 ANDA207985 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 7 BLISTER PACK in 1 CARTON (68462-166-07) / 7 CAPSULE in 1 BLISTER PACK
  • 28 CARTON in 1 CARTON (68462-166-15) / 14 BLISTER PACK in 1 CARTON (68462-166-41) / 14 CAPSULE in 1 BLISTER PACK
  • 30 CAPSULE in 1 BOTTLE (68462-166-30)
source: ndc

Packages (3)

68462-166-07 7 BLISTER PACK in 1 CARTON (68462-166-07) / 7 CAPSULE in 1 BLISTER PACK 68462-166-15 28 CARTON in 1 CARTON (68462-166-15) / 14 BLISTER PACK in 1 CARTON (68462-166-41) / 14 CAPSULE in 1 BLISTER PACK 68462-166-30 30 CAPSULE in 1 BOTTLE (68462-166-30)

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": "6640fd85-57d1-4ec5-b555-8dce3037d409", "openfda": {"upc": ["0368462166307"], "unii": ["G926EC510T"], "rxcui": ["1012895"], "spl_set_id": ["8fe14efd-8f61-40db-9069-bb17daf3261a"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "7 BLISTER PACK in 1 CARTON (68462-166-07)  / 7 CAPSULE in 1 BLISTER PACK", "package_ndc": "68462-166-07", "marketing_start_date": "20220928"}, {"sample": false, "description": "28 CARTON in 1 CARTON (68462-166-15)  / 14 BLISTER PACK in 1 CARTON (68462-166-41)  / 14 CAPSULE in 1 BLISTER PACK", "package_ndc": "68462-166-15", "marketing_start_date": "20220928"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (68462-166-30)", "package_ndc": "68462-166-30", "marketing_start_date": "20220928"}], "brand_name": "fingolimod", "product_id": "68462-166_6640fd85-57d1-4ec5-b555-8dce3037d409", "dosage_form": "CAPSULE", "pharm_class": ["Sphingosine 1-Phosphate Receptor Modulators [MoA]", "Sphingosine 1-phosphate Receptor Modulator [EPC]"], "product_ndc": "68462-166", "generic_name": "fingolimod", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "fingolimod", "active_ingredients": [{"name": "FINGOLIMOD HYDROCHLORIDE", "strength": ".5 mg/1"}], "application_number": "ANDA207985", "marketing_category": "ANDA", "marketing_start_date": "20220928", "listing_expiration_date": "20271231"}