NDC 63850-0107-01 - Everolimus

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
63850-0107
Requested NDC
63850-0107-01
Package NDCs from labels
63850-0107-1, 63850-0107-2, 63850-0107-3, 63850-0107-01
Manufacturer
Natco Pharma Limited | Natco Pharma Limited-Pharma Division
Effective date
2025-10-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Everolimus - Natco Pharma Limited | Natco Pharma Limited-Pharma DivisionNatco Pharma Limited | Natco Pharma Limited-Pharma Division2025-10-14Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63850-0107-1Everolimus10 in 1 BLISTER PACKTABLET105
63850-0107-2Everolimus60 in 1 CARTONTABLET605
63850-0107-3Everolimus60 in 1 BOTTLETABLET605

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 2 of 3 · 57 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
everolimusEVEROLIMUSNovugen Pharma (USA) LLC.67e62e26-448d-46ec-b5a1-00dc1b5e26c62026-03-10Warnings, Adverse reactionsExact identifier
unii: 9HW64Q8G6G
Artificial TearsGLYCERINPreferred Pharmaceuticals Inc.dd646c72-8f47-43c6-a734-db0dcc8cd4d12026-03-06WarningsExact identifier
unii: 3NXW29V3WO
everolimusEVEROLIMUSAurobindo Pharma Limited43ef3c29-0e25-4fdd-aea1-06a20af9bbab2026-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2056895
rxcui: 977427
rxcui: 977434
rxcui: 977438
unii: 9HW64Q8G6G
Discount Drug Mart Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Discount Drug Martf7fd53be-e501-d97f-e053-6394a90ad4092025-12-30WarningsExact identifier
unii: 3NXW29V3WO
Exchange Select Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Army and Air Force Exchange Service9e478343-8ae7-823e-e053-2995a90a84ed2025-12-30WarningsExact identifier
unii: 3NXW29V3WO
DG Health Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYPROPYLENE GLYCOL 400Dolgencorp LLC9cb20c3b-bf6d-8c7c-e053-2995a90aa4852025-12-30WarningsExact identifier
unii: 3NXW29V3WO
Core Values Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Liberty Procurement Co. Inc.f8285f68-c40c-19a8-e053-6394a90aacad2025-12-30WarningsExact identifier
unii: 3NXW29V3WO
Harris Teeter Eye Drops Artificial TearsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Harris Teeter, LLC.f82957d9-c4ad-a914-e053-6294a90aac502025-12-30WarningsExact identifier
unii: 3NXW29V3WO
CVS Gentle TearsDEXTRAN 70, HYPROMELLOSECVS Pharmacy, Inc.9b1ea0eb-c34f-6603-e053-2995a90a6a952025-12-30WarningsExact identifier
unii: 3NXW29V3WO
EverolimusEVEROLIMUSAscend Laboratories, LLC2693c497-a70b-4d00-b6db-602c872e5bed2025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2056895
rxcui: 977427
rxcui: 977434
rxcui: 977438
unii: 9HW64Q8G6G
Artificial TearsGLYCERINGeri-Care Pharmaceuticals, Corp7cc437e3-bad9-59be-e053-2991aa0a1da32025-12-19WarningsExact identifier
unii: 3NXW29V3WO
Artificial TearsGLYCERINNuCare Pharmaceuticals,Inc.97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d2025-12-15WarningsExact identifier
unii: 3NXW29V3WO
EverolimusEVEROLIMUSNatco Pharma Limitedd44998bb-5deb-4ee7-a0a5-979fe3f495572025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205432
ndc (package): 63850-0107-3
ndc (package): 63850-0107-1
ndc (package): 63850-0063-2
ndc (package): 63850-0062-6
ndc (package): 63850-0062-2
ndc (package): 63850-0063-3
ndc (package): 63850-0107-2
ndc (package): 63850-0064-2
ndc (package): 63850-0063-6
ndc (package): 63850-0062-3
ndc (package): 63850-0064-6
ndc (product): 63850-0063
ndc (product): 63850-0107
ndc (product): 63850-0062
ndc (product): 63850-0064
ndc11 (package): 63850010701
rxcui: 2056895
rxcui: 977427
rxcui: 977434
rxcui: 977438
spl id: 111c2e93-390f-40c6-a626-6aa45878a801
spl set id: d44998bb-5deb-4ee7-a0a5-979fe3f49557
unii: 9HW64Q8G6G
EverolimusEVEROLIMUSBreckenridge Pharmaceutical, Inc.01f7b5fb-be0d-4adf-acd2-6899018de9662025-09-05Warnings, Adverse reactionsExact identifier
unii: 9HW64Q8G6G
EverolimusEVEROLIMUSBiocon Pharma Inc.435da284-ef0e-ca90-e0db-bab9382922e02025-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2056895
rxcui: 977427
rxcui: 977434
rxcui: 977438
unii: 9HW64Q8G6G
EVEROLIMUSEVEROLIMUSBiocon Pharma Inc.5fb55800-f322-6bb6-9dde-622925ef28bd2025-03-21Warnings, Adverse reactionsExact identifier
unii: 9HW64Q8G6G
Advanced Eye Relief/ Redness Maximum ReliefNAPHAZOLINE HYDROCHLORIDE AND HYPROMELLOSEBausch & Lomb Incorporated3c11285a-7e86-4b47-b1ee-e7d59858087d2024-09-25WarningsExact identifier
unii: 3NXW29V3WO
EverolimusEVEROLIMUSHikma Pharmaceuticals USA Inc.cf2dd54b-7a1d-4401-9a01-75e68235e4332024-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2056895
rxcui: 977427
rxcui: 977434
rxcui: 977438
unii: 9HW64Q8G6G
Multi-PhenolicMANNOSE, 5-HYDROXYTRYPTOPHAN, ACETALDEHYDE, ACETYLCHOLINE CHLORIDE, ASCORBICUM ACIDUM, ASPARTAME, BUTYLATED HYDROXYTOLUENE, CAFFEIC ACID, CANDIDA ALBICANS, CINNAMIC ACID, CONIFERYL ALCOHOL, COUMARINUM, DOPAMINE HYDROCHLORIDE, ESTRADIOL, GABA (GAMMA-AMINOBUTYRIC ACID), GALLICUM ACIDUM, HISTAMINUM HYDROCHLORICUM, HYDROCORTISONE, INDOLUM, L-DOPA, L-PHENYLALANINE, MELATONIN, MENADIONE, NOREPINEPHRINE (BITARTRATE), PETROSELINUM CRISPUM, PHENYL ISOTHIOCYANATE, PIPERINE, PROGESTERONE, PYRROLE, QUERCETIN,Energique, Inc.492b412a-01cc-48f2-bcdc-6fffcc6519632024-08-23WarningsExact identifier
unii: 1P9D0Z171K
EVEROLIMUSEVEROLIMUSNorthStar RxLLC5cfca904-b75c-5a39-8cb9-b99bb421bceb2024-08-02Warnings, Adverse reactionsExact identifier
unii: 9HW64Q8G6G

Reported adverse events (FAERS/openFDA)#

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