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 14 of 106 · 2,108 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OLANZAPINEOLANZAPINEAnthea Pharma Private Limitede6ffcc56-63f9-4b12-a07a-c6177ffef5e82026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEMacleods Pharmaceuticals Limited8e095987-bdea-42f2-9550-c7155cf07d302026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202862
ndc (product): 33342-071
rxcui: 200034
rxcui: 283639
rxcui: 312079
rxcui: 312077
rxcui: 314154
rxcui: 312078
spl id: 2b861570-6b18-4b2b-89aa-29ebde7770f5
spl set id: 8e095987-bdea-42f2-9550-c7155cf07d30
unii: N7U69T4SZR
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL B50OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION4490f968-46b6-44d2-af2d-5130b52c88612026-03-05WarningsExact identifier
unii: 15FIX9V2JP
OlanzapineOLANZAPINEMacleods Pharmaceuticals Limiteddf43938a-3469-40eb-8166-f0a2fd29d6d82026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OLANZAPINEOLANZAPINETorrent Pharmaceuticals Limited2cb1bebe-0ced-46d8-bf21-c28a9acc4a152026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200034
rxcui: 283639
rxcui: 312079
rxcui: 312077
rxcui: 314154
rxcui: 312078
unii: N7U69T4SZR
OlanzapineOLANZAPINEAmerican Regent, Inc.e9ac2bd3-dbff-4b1a-952f-da3909c6e4ee2026-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINETeva Pharmaceuticals USA, Inc.dd0b2525-4e2f-44fc-9302-0ae4ebb1e1352026-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
TIBENA EVERY DAY REAL SUN BLOCKTITANIUM DIOXIDE, ZINC OXIDEKONAD CO LTD211c9930-4f91-cf8f-e063-6394a90a97b32026-02-26WarningsExact identifier
unii: 15FIX9V2JP
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION MATTE M B10TITANIUM DIOXIDEShiseido Americas Corporation54f8210f-4934-4ada-89c3-aa89e7a092602026-02-26WarningsExact identifier
unii: 15FIX9V2JP
OlanzapineOLANZAPINESandoz Incc44a96cc-817d-4eb5-a13a-00977f76e6662026-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
SHISEIDO UV PROTECTIVE COMPACT (REFILL) FAIR IVORYOCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONc05cef12-a6a7-4682-9357-6d77f4ca32672026-02-25WarningsExact identifier
unii: 15FIX9V2JP
cle de peau BEAUTE RADIANT FOUNDATION N M I10OCTINOXATE AND TITANIUM DIOXIDEShiseido Americas Corporation3be1fe06-bd3b-4078-bee9-d3caf8d068ff2026-02-25WarningsExact identifier
unii: 15FIX9V2JP
cle de peau BEAUTE THE FOUNDATION N M O20OCTINOXATE AND TITANIUM DIOXIDEShiseido Americas Corporation9507f6d1-c11c-428d-8d95-b436f27ba26a2026-02-24WarningsExact identifier
unii: 15FIX9V2JP
Perfect Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN PERFECT MEDICAL4b93538a-3b3e-90f7-e063-6294a90ab8982026-02-24WarningsExact identifier
unii: 15FIX9V2JP
ANTI-AGING TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b93cd22-1289-29bc-e063-6294a90ab7812026-02-24WarningsExact identifier
unii: 15FIX9V2JP
ANTI-AGING TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b943d72-dcde-e2e4-e063-6294a90ab7c42026-02-24WarningsExact identifier
unii: 15FIX9V2JP
ANTI-AGING NON-TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b946c39-718b-d70e-e063-6394a90a0db82026-02-24WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO URBAN ENVIRONMENT MINERAL CLEAR SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEShiseido Americas Corporationb93f10dc-193d-4cda-94b6-3f0e54d89f212026-02-23WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO ULTIMATE SUN PROTECTOR MINERALTITANIUM DIOXIDE AND ZINC OXIDESHISEIDO AMERICAS CORPORATION5e31eee8-6532-47ea-99fc-22418791804b2026-02-23WarningsExact identifier
unii: 15FIX9V2JP
OlanzapineOLANZAPINEAmerican Health Packagingc0d705bf-b719-4c7b-b83d-c17d41cbbfad2026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283639
rxcui: 312077
unii: N7U69T4SZR

Reported adverse events (FAERS/openFDA)#

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