fingolimod

Generic: fingolimod

Labeler: dr. reddy's laboratories inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fingolimod
Generic Name fingolimod
Labeler dr. reddy's laboratories inc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fingolimod hydrochloride .5 mg/1

Manufacturer
Dr. Reddy's Laboratories Inc

Identifiers & Regulatory

Product NDC 43598-285
Product ID 43598-285_1d9a673c-7eb0-b5c3-eb90-9abce3ef9141
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208000
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 43598285
Hyphenated Format 43598-285

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 ANDA208000 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (43598-285-30)
  • 3 BLISTER PACK in 1 CARTON (43598-285-31) / 10 CAPSULE in 1 BLISTER PACK (43598-285-79)
  • 1 BLISTER PACK in 1 CARTON (43598-285-70) / 7 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (3)

43598-285-30 30 CAPSULE in 1 BOTTLE (43598-285-30) 43598-285-31 3 BLISTER PACK in 1 CARTON (43598-285-31) / 10 CAPSULE in 1 BLISTER PACK (43598-285-79) 43598-285-70 1 BLISTER PACK in 1 CARTON (43598-285-70) / 7 CAPSULE in 1 BLISTER PACK

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": "1d9a673c-7eb0-b5c3-eb90-9abce3ef9141", "openfda": {"unii": ["G926EC510T"], "rxcui": ["1012895"], "spl_set_id": ["56badc2a-6747-9284-300e-bf072eb072ed"], "manufacturer_name": ["Dr. Reddy's Laboratories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (43598-285-30)", "package_ndc": "43598-285-30", "marketing_start_date": "20221011"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (43598-285-31)  / 10 CAPSULE in 1 BLISTER PACK (43598-285-79)", "package_ndc": "43598-285-31", "marketing_start_date": "20221011"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (43598-285-70)  / 7 CAPSULE in 1 BLISTER PACK", "package_ndc": "43598-285-70", "marketing_start_date": "20221011"}], "brand_name": "Fingolimod", "product_id": "43598-285_1d9a673c-7eb0-b5c3-eb90-9abce3ef9141", "dosage_form": "CAPSULE", "pharm_class": ["Sphingosine 1-Phosphate Receptor Modulators [MoA]", "Sphingosine 1-phosphate Receptor Modulator [EPC]"], "product_ndc": "43598-285", "generic_name": "Fingolimod", "labeler_name": "Dr. Reddy's Laboratories Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fingolimod", "active_ingredients": [{"name": "FINGOLIMOD HYDROCHLORIDE", "strength": ".5 mg/1"}], "application_number": "ANDA208000", "marketing_category": "ANDA", "marketing_start_date": "20221011", "listing_expiration_date": "20261231"}