FDA.reportPublic FDA data

NDC 68462-166-41 - fingolimod

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68462-166
Requested NDC
68462-166-41
Package NDCs from labels
68462-166-30, 68462-166-07, 68462-166-41, 68462-166-15
Manufacturer
Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited
Effective date
2026-01-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
fingolimod - Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals LimitedGlenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited2026-01-31HUMAN PRESCRIPTION DRUG LABEL
fingolimod - Skya Health, LLCSkya Health, LLC2024-03-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-166-07fingolimod7 in 1 BLISTER PACKCAPSULE75
68462-166-07fingolimod7 in 1 CARTONCAPSULE75
68462-166-15fingolimod28 in 1 CARTONCAPSULE285
68462-166-30fingolimod30 in 1 BOTTLECAPSULE305
68462-166-41fingolimod14 in 1 CARTONCAPSULE145
68462-166-41fingolimod14 in 1 BLISTER PACKCAPSULE145

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-166FINGOLIMOD CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]4Current NDC, Legacy NDC, 6 package rows20240724_8fe14efd-8f61-40db-9069-bb17daf3261a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-166-30EA - Each68462-1669f85449d-f304-43f5-ae8e-b24b1d24436a12022-11-07

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 54 of 101 · 2,007 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clinical Skin Filter Tinted SunscreenCLINICAL SKIN FILTER TINTED SUNSCREENKRX RESOURCES SDN. BHD.22b8856b-671f-def3-e063-6394a90a4ea02025-10-18WarningsExact identifier
unii: 15FIX9V2JP
Clinical Skin Filter Tinted Sunscreen Medium DarkCLINICAL SKIN FILTER TINTED SUNSCREEN MEDIUM DARKKRX RESOURCES SDN. BHD.22cead37-f862-e859-e063-6394a90a86ce2025-10-18WarningsExact identifier
unii: 15FIX9V2JP
Krx Aesthetics All Day Glow SunblockerKRX AESTHETICS ALL DAY GLOW SUNBLOCKERKRX RESOURCES SDN. BHD.22a60fb9-0fea-92c0-e063-6394a90a088c2025-10-18WarningsExact identifier
unii: 15FIX9V2JP
FINGOLIMOD HYDROCHLORIDEFINGOLIMOD HYDROCHLORIDEAccord Healthcare Inc.65e59a51-c9c2-47b4-84fc-e0f8879eb26c2025-10-16Warnings, Adverse reactionsExact identifier
rxcui: 1012895
unii: G926EC510T
DD CreamDD CREAMDERMAdoctor, Inc.08c9a0cf-ee78-483b-e054-00144ff88e882025-10-16WarningsExact identifier
unii: 15FIX9V2JP
Ciele Filter and ProtectTITANIUM DIOXIDE, ZINC OXIDECiele0309b0ef-baca-b41d-e063-6294a90a49d72025-10-15WarningsExact identifier
unii: 15FIX9V2JP
Defend and Balance TInted Mineral Sunscreen SPF 50SUNSCREENEpicuren Discovery41367f05-59d8-6736-e063-6394a90a5f172025-10-15WarningsExact identifier
unii: 15FIX9V2JP
Skinlycious Multi Protection Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE , ZINC OXIDESkinlycious Pte Ltde0ad02c3-f5ed-4b72-ba96-07d9c489a4ea2025-10-13WarningsExact identifier
unii: 15FIX9V2JP
Vertra S Dorian Kona Gold Signature Face Stick SPF 38TITANIUM DIOXIDEEai-jr 286, Incb6c316c3-661b-6428-e053-2a95a90a1a6b2025-10-10WarningsExact identifier
unii: 15FIX9V2JP
Dr Lift Mineral SPF 50TITANIUM DIOXIDE, ZINC OXIDESpa de Soleil40c03d65-8d09-371a-e063-6294a90a7ac62025-10-09WarningsExact identifier
unii: 15FIX9V2JP
Dr Lift Mineral SPF 30TITANIUM DIOXIDESpa de Soleil40c0e0d2-2c1d-e629-e063-6394a90a5aaf2025-10-09WarningsExact identifier
unii: 15FIX9V2JP
Essential Defense Mineral Shield Broad Spectrum SPF 35 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEAllergan, Inc.29817fdc-f14c-4013-a8ed-4367f3b2867c2025-10-09WarningsExact identifier
unii: 15FIX9V2JP
Vertra Pearl White Face Stick SPF 50PADIMATE O, TITANIUM DIOXIDEEai-jr 286, Incb69a75e0-8724-35ae-e053-2a95a90a5f342025-10-07WarningsExact identifier
unii: 15FIX9V2JP
Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta BeigeTITANIUM DIOXIDEEAI-JR 286, Inc.b9ea12e8-6ed9-d805-e053-2a95a90aa1072025-10-07WarningsExact identifier
unii: 15FIX9V2JP
SPF50 SunscreenSUNSCREENKINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTDb3cde609-7d62-2ac7-e053-2a95a90a26b32025-10-07Exact identifier
unii: 15FIX9V2JP
Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta BeigeTITANIUM DIOXIDEToshiki Pigment Co., Ltd.b9eba15f-493a-43c9-e053-2995a90a04512025-10-06WarningsExact identifier
unii: 15FIX9V2JP
PURE SOL SPF 37 Tinted MoisturizerZINC OXIDE TITANIUM DIOXIDEBrand 2022b LLC4052c4e4-2105-80c0-e063-6294a90af41d2025-10-04WarningsExact identifier
unii: 15FIX9V2JP
Kids Mineral Sunscreen SPF50SUNSCREENHello Bello01cc554b-9241-d891-e063-6394a90a84502025-10-02WarningsExact identifier
unii: 15FIX9V2JP
toty Ilumina CC Creamy Compact Refill 1CTITANIUM DIOXIDEChipican LLCf0596830-77ed-11f0-e053-2995a90a8ff52025-09-29WarningsExact identifier
unii: 15FIX9V2JP
U V-Lamp Shield Mani-SunscreenZINC OXIDE, TITANIUM DIOXIDEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3fe7e1c3-e6cd-1420-e063-6394a90a41382025-09-28WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.