FDA.reportPublic FDA data

NDC 68084-528-11 - 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
68084-528
Requested NDC
68084-528-11
Package NDCs from labels
68084-528-11, 68084-528-01
Manufacturer
American Health Packaging
Effective date
2026-02-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Olanzapine - American Health PackagingAmerican Health Packaging2026-02-20HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-528-01Olanzapine100 in 1 BOX, UNIT-DOSETABLET, FILM COATED10011
68084-528-11Olanzapine1 in 1 BLISTER PACKTABLET, FILM COATED111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-528OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]10Current NDC, Legacy NDC, 2 package rows20240522_c0d705bf-b719-4c7b-b83d-c17d41cbbfad.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-528-01EA - Each68084-52830da7dfa-0f64-4b55-a3d0-9a7108c06a6712012-07-24
68084-528-11EA - Each68084-5282cf86d14-92d8-4a5d-ab48-2fb2a16190a012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
olanzapineACTIVE INGREDIENTN7U69T4SZROLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
OLANZAPINEACTIVE MOIETYN7U69T4SZROLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
CrospovidoneINACTIVE INGREDIENT68401960MKOLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671POLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
hypromellosesINACTIVE INGREDIENT3NXW29V3WOOLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XOLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
magnesium stearateINACTIVE INGREDIENT70097M6I30OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQOLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPOLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4

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 3 of 113 · 2,242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OlanzapineOLANZAPINEREMEDYREPACK INC.3d69af75-7615-4ec2-b7ef-467b2558c5c82026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEDr. Reddy's Laboratories Ltd.a4c525da-c2f6-b804-af49-6012959222542026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076133
ndc (product): 55111-168
ndc (product): 55111-167
rxcui: 283639
rxcui: 312077
spl id: 2f861c8a-30f2-1080-95fb-1eba71d613b8
spl set id: a4c525da-c2f6-b804-af49-601295922254
unii: N7U69T4SZR
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
OlanzapineOLANZAPINEREMEDYREPACK INC.ad350abc-a1fc-4be4-b2be-c629121552a02026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076133
rxcui: 283639
unii: N7U69T4SZR
OlanzapineOLANZAPINEREMEDYREPACK INC.b513823d-927c-4111-8766-e6c37f84b2212026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEREMEDYREPACK INC.68de2a51-69b2-4d99-be79-36a95a4bc4752026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
unii: 15FIX9V2JP
OlanzapineOLANZAPINEMajor Pharmaceuticals0ecbf540-572e-4ca4-b694-18ca1cd1c1942026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEREMEDYREPACK INC.1705bab2-a2f8-4534-b1fc-eb309cd2696b2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076133
rxcui: 312077
unii: N7U69T4SZR
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: 3NXW29V3WO
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
unii: 15FIX9V2JP
OlanzapineOLANZAPINECamber Pharmaceuticals, Inc.c1387008-6dc4-4f1e-ae29-fa7a0f0be6842026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
unii: 15FIX9V2JP
Evereden Fluid Silk Mineral Sunscreen PRO SPF50TITANIUM DIOXIDE, ZINC OXIDEEden Brands Inc.2cb7773f-9a05-ad02-e063-6294a90af0242026-07-01WarningsExact identifier
unii: 15FIX9V2JP
OlanzapineOLANZAPINEREMEDYREPACK INC.8e5ef52d-315b-4055-9e52-403e6f896f242026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
olanzapineOLANZAPINEBionpharma Inc.8f485576-a4c4-45d4-816f-2e59fce9f5172026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OHUI Ultimate Cover CC Cushion Compact 01 Light BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d2f9c54b-ac4e-5141-e053-2a95a90aa2b82026-06-30WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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