fingolimod hydrochloride

Generic: fingolimod hydrochloride

Labeler: accord healthcare inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fingolimod hydrochloride
Generic Name fingolimod hydrochloride
Labeler accord healthcare inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fingolimod hydrochloride .5 mg/1

Manufacturer
Accord Healthcare Inc.

Identifiers & Regulatory

Product NDC 16729-342
Product ID 16729-342_4148bb57-7d2c-1724-e063-6294a90a34fd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207991
Listing Expiration 2026-12-31
Marketing Start 2022-10-18

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 16729342
Hyphenated Format 16729-342

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 hydrochloride (source: ndc)
Generic Name fingolimod hydrochloride (source: ndc)
Application Number ANDA207991 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (16729-342-10)
source: ndc

Packages (1)

16729-342-10 30 CAPSULE in 1 BOTTLE (16729-342-10)

Ingredients (1)

fingolimod hydrochloride (.5 mg/1)

Linked Drug Pages (1)

FINGOLIMOD HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4148bb57-7d2c-1724-e063-6294a90a34fd", "openfda": {"unii": ["G926EC510T"], "rxcui": ["1012895"], "spl_set_id": ["65e59a51-c9c2-47b4-84fc-e0f8879eb26c"], "manufacturer_name": ["Accord Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (16729-342-10)", "package_ndc": "16729-342-10", "marketing_start_date": "20221018"}], "brand_name": "FINGOLIMOD HYDROCHLORIDE", "product_id": "16729-342_4148bb57-7d2c-1724-e063-6294a90a34fd", "dosage_form": "CAPSULE", "pharm_class": ["Sphingosine 1-Phosphate Receptor Modulators [MoA]", "Sphingosine 1-phosphate Receptor Modulator [EPC]"], "product_ndc": "16729-342", "generic_name": "FINGOLIMOD HYDROCHLORIDE", "labeler_name": "Accord Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FINGOLIMOD HYDROCHLORIDE", "active_ingredients": [{"name": "FINGOLIMOD HYDROCHLORIDE", "strength": ".5 mg/1"}], "application_number": "ANDA207991", "marketing_category": "ANDA", "marketing_start_date": "20221018", "listing_expiration_date": "20261231"}