fingolimod

Generic: fingolimod hydrochloride

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fingolimod
Generic Name fingolimod hydrochloride
Labeler ascend laboratories, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fingolimod hydrochloride .5 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-476
Product ID 67877-476_022f1ebe-0d03-4ba1-853e-91f1e81ed59b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208004
Listing Expiration 2026-12-31
Marketing Start 2022-09-21

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 67877476
Hyphenated Format 67877-476

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 hydrochloride (source: ndc)
Application Number ANDA208004 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (67877-476-30)
  • 7 BLISTER PACK in 1 CARTON (67877-476-32) / 7 CAPSULE in 1 BLISTER PACK
  • 10 BLISTER PACK in 1 CARTON (67877-476-33) / 10 CAPSULE in 1 BLISTER PACK
  • 28 CAPSULE in 1 BOTTLE (67877-476-56)
  • 28 BLISTER PACK in 1 CARTON (67877-476-58) / 14 CAPSULE in 1 BLISTER PACK (67877-476-14)
source: ndc

Packages (5)

67877-476-30 30 CAPSULE in 1 BOTTLE (67877-476-30) 67877-476-32 7 BLISTER PACK in 1 CARTON (67877-476-32) / 7 CAPSULE in 1 BLISTER PACK 67877-476-33 10 BLISTER PACK in 1 CARTON (67877-476-33) / 10 CAPSULE in 1 BLISTER PACK 67877-476-56 28 CAPSULE in 1 BOTTLE (67877-476-56) 67877-476-58 28 BLISTER PACK in 1 CARTON (67877-476-58) / 14 CAPSULE in 1 BLISTER PACK (67877-476-14)

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": "022f1ebe-0d03-4ba1-853e-91f1e81ed59b", "openfda": {"unii": ["G926EC510T"], "rxcui": ["1012895"], "spl_set_id": ["0f638feb-6986-41e4-8f9c-2e6b84a5bb44"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (67877-476-30)", "package_ndc": "67877-476-30", "marketing_start_date": "20220921"}, {"sample": false, "description": "7 BLISTER PACK in 1 CARTON (67877-476-32)  / 7 CAPSULE in 1 BLISTER PACK", "package_ndc": "67877-476-32", "marketing_start_date": "20220921"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (67877-476-33)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "67877-476-33", "marketing_start_date": "20220921"}, {"sample": false, "description": "28 CAPSULE in 1 BOTTLE (67877-476-56)", "package_ndc": "67877-476-56", "marketing_start_date": "20220921"}, {"sample": false, "description": "28 BLISTER PACK in 1 CARTON (67877-476-58)  / 14 CAPSULE in 1 BLISTER PACK (67877-476-14)", "package_ndc": "67877-476-58", "marketing_start_date": "20220921"}], "brand_name": "Fingolimod", "product_id": "67877-476_022f1ebe-0d03-4ba1-853e-91f1e81ed59b", "dosage_form": "CAPSULE", "pharm_class": ["Sphingosine 1-Phosphate Receptor Modulators [MoA]", "Sphingosine 1-phosphate Receptor Modulator [EPC]"], "product_ndc": "67877-476", "generic_name": "Fingolimod hydrochloride", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fingolimod", "active_ingredients": [{"name": "FINGOLIMOD HYDROCHLORIDE", "strength": ".5 mg/1"}], "application_number": "ANDA208004", "marketing_category": "ANDA", "marketing_start_date": "20220921", "listing_expiration_date": "20261231"}