fingolimod

Generic: fingolimod

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

Drug Facts

Product Profile

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

fingolimod hydrochloride .5 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-912
Product ID 68382-912_37d21196-e2e4-45ce-a16c-f8e8693c94de
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 68382912
Hyphenated Format 68382-912

Supplemental Identifiers

RxCUI
1012895
UPC
0368382912060
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 (68382-912-01)
  • 30 CAPSULE in 1 BOTTLE (68382-912-06)
  • 90 CAPSULE in 1 BOTTLE (68382-912-16)
  • 1 BLISTER PACK in 1 CARTON (68382-912-69) / 7 CAPSULE in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 CARTON (68382-912-70) / 7 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (5)

68382-912-01 100 CAPSULE in 1 BOTTLE (68382-912-01) 68382-912-06 30 CAPSULE in 1 BOTTLE (68382-912-06) 68382-912-16 90 CAPSULE in 1 BOTTLE (68382-912-16) 68382-912-69 1 BLISTER PACK in 1 CARTON (68382-912-69) / 7 CAPSULE in 1 BLISTER PACK 68382-912-70 4 BLISTER PACK in 1 CARTON (68382-912-70) / 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": "37d21196-e2e4-45ce-a16c-f8e8693c94de", "openfda": {"upc": ["0368382912060"], "unii": ["G926EC510T"], "rxcui": ["1012895"], "spl_set_id": ["e738dbd9-f4cc-49a0-98ce-73dd0c3ff3b3"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (68382-912-01)", "package_ndc": "68382-912-01", "marketing_start_date": "20221011"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (68382-912-06)", "package_ndc": "68382-912-06", "marketing_start_date": "20221011"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (68382-912-16)", "package_ndc": "68382-912-16", "marketing_start_date": "20221011"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (68382-912-69)  / 7 CAPSULE in 1 BLISTER PACK", "package_ndc": "68382-912-69", "marketing_start_date": "20221011"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (68382-912-70)  / 7 CAPSULE in 1 BLISTER PACK", "package_ndc": "68382-912-70", "marketing_start_date": "20221011"}], "brand_name": "Fingolimod", "product_id": "68382-912_37d21196-e2e4-45ce-a16c-f8e8693c94de", "dosage_form": "CAPSULE", "pharm_class": ["Sphingosine 1-Phosphate Receptor Modulators [MoA]", "Sphingosine 1-phosphate Receptor Modulator [EPC]"], "product_ndc": "68382-912", "generic_name": "Fingolimod", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "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"}