FDA.reportPublic FDA data

NDC 70518-2375-01 - Olanzapine

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
70518-2375
Requested NDC
70518-2375-01
Package NDCs from labels
70518-2375-0, 70518-2375-1, 70518-2375-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-03-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Olanzapine - REMEDYREPACK INC.REMEDYREPACK INC.2026-03-26HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-03-09These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996
2023-03-09These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996
2023-01-30These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996
2023-01-30These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2375-0Olanzapine30 in 1 BLISTER PACKTABLET, FILM COATED309
70518-2375-1Olanzapine30 in 1 BLISTER PACKTABLET, FILM COATED309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2375OLANZAPINE TABLET, FILM COATED [REMEDYREPACK INC.]6Current NDC, Legacy NDC, 2 package rows20250124_76a6ff21-7157-4213-8073-35837a3ac07e.zip

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 12 of 106 · 2,108 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunscreen for baby SPF50plusOCTOCRYLENE,ETHYLHEXYL METHOXYCINNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATEGuangzhou Senmai Biotechnology Co., Ltd.1cb7fbca-0874-ae53-e063-6294a90ab42a2026-04-02WarningsExact identifier
unii: 15FIX9V2JP
TiZO3TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD4e7bdec2-abcc-0267-e063-6394a90ae47a2026-04-02WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc17b47994-82d6-4f9d-8249-bdb55106c9b32026-04-02WarningsExact identifier
unii: 15FIX9V2JP
Clinical Skin Filter Tinted SunscreenCLINICAL SKIN FILTER TINTED SUNSCREENBY KIN AESTHETICS LLC4e69a8a3-8dbb-577a-e063-6294a90a6a232026-04-01WarningsExact identifier
unii: 15FIX9V2JP
Krx Aesthetics All Day Glow SunblockerKRX AESTHETICS ALL DAY GLOW SUNBLOCKERBY KIN AESTHETICS LLC4e69df43-393b-bc09-e063-6394a90a275a2026-04-01WarningsExact identifier
unii: 15FIX9V2JP
spf 50 mineral powder sunscreenTITANIUM DIOXIDE, ZINC OXIDESmalls Brand LLC DBA Roe Wellnessf8762dd1-0484-74ea-e053-6294a90ac1122026-03-31WarningsExact identifier
unii: 15FIX9V2JP
SeranovaTM ULTRALIGHT SPF50 SERUMSERANOVATM ULTRALIGHT SPF50 SERUMGuangzhou Ariel Biotech Co., Ltd.4e5d716d-2b2d-d42f-e063-6294a90a1e522026-03-31WarningsExact identifier
unii: 15FIX9V2JP
Olanzapine and FluoxetineOLANZAPINE AND FLUOXETINETeva Pharmaceuticals USA, Inc.3c28cf18-01a3-468a-ab3e-8aa82f9182512026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEXGen Pharmaceuticals DJB, Inc.3aad0f7b-8d0c-a9bf-e063-6394a90a6ae82026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
UV SOLUTIONS BRIGHTENING TINTED BROAD SPECTRUM SPF 50 SUNSCREEN NIACINAMIDE ANTIOXIDANTS DARK SHADETITANIUM DIOXIDE AND ZINC OXIDECLINIQUE LABORATORIES LLC4e0bd355-99c6-8cf4-e063-6294a90ab4b32026-03-27WarningsExact identifier
unii: 15FIX9V2JP
OlanzapineOLANZAPINEStrides Pharma Science Limited979c3212-36e8-4287-aace-bef0875188d72026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEREMEDYREPACK INC.76a6ff21-7157-4213-8073-35837a3ac07e2026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202862
ndc (package): 70518-2375-1
ndc (package): 70518-2375-0
ndc (product): 70518-2375
ndc11 (package): 70518237501
rxcui: 312077
spl id: 4dee069c-5579-00b9-e063-6394a90a168d
spl set id: 76a6ff21-7157-4213-8073-35837a3ac07e
unii: N7U69T4SZR
SUNNYSIDEKICK UVA/UVB Broad Spectrum SPF 30 Brush-On MineralZINC OXIDE, TITANIUM DIOXIDEClassic Cosmetics LLC4df3b8c0-71bc-acdd-e063-6394a90a35c02026-03-26WarningsExact identifier
unii: 15FIX9V2JP
Silkscreen Sheer Tint Mineral Light-MediumTITANIUM DIOXIDE, ZINC OXIDECurology4ddbe349-6880-a5fc-e063-6294a90a275c2026-03-25WarningsExact identifier
unii: 15FIX9V2JP
BANANA BOATTITANIUM DIOXIDE,ZINC OXIDEEdgewell Personal Care Brands LLC4e0450ca-147a-91d7-e063-6394a90ae73b2026-03-25WarningsExact identifier
unii: 15FIX9V2JP
Sunscreen SPF 50SUNSCREEN SPF 50Guangzhou Ariel Biotech Co., Ltd.4dd05620-30a3-9cea-e063-6294a90af18b2026-03-24WarningsExact identifier
unii: 15FIX9V2JP
Sunscreen SPF 50SUNSCREEN SPF 50Guangzhou Ariel Biotech Co., Ltd.4dd1b722-4448-9675-e063-6294a90a5f4f2026-03-24WarningsExact identifier
unii: 15FIX9V2JP
WHAMISA ORGANIC PEAR BLOSSOM SUNSCREENZINC OXIDEENS KOREA Co., Ltd.34f9688d-efa1-1d3f-e063-6294a90ab1272026-03-23WarningsExact identifier
unii: 15FIX9V2JP
HALORINNA SUN-SCREEN TRAVEL SPF50SUN SCREENGuangdong Bisutang Biotechnology Co., LTD4dade579-ce77-eea5-e063-6394a90ad46a2026-03-23WarningsExact identifier
unii: 15FIX9V2JP
Olanzapine IntramuscularOLANZAPINEUBI Pharma Inc.6a279fe1-ed99-4a62-b2c7-831961470fa92026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR

Reported adverse events (FAERS/openFDA)#

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