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 6 of 113 · 2,242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Mattescreen SPF 40 - UntintedTITANIUM DIOXIDE, ZINC OXIDESupergoop, LLC08671d39-3be2-d666-e063-6294a90a62072026-06-04WarningsExact identifier
unii: 15FIX9V2JP
Mineral Mattescreen SPF 40 - Golden HourTITANIUM DIOXIDE, ZINC OXIDESupergoop, LLCc2398820-f003-707f-e053-2a95a90a69292026-06-04WarningsExact identifier
unii: 15FIX9V2JP
Epionce Daily Shield Tinted SPF 50TITANIUM DIOXIDE, ZINC OXIDEEpisciences, Inc.3d1e2921-cba9-4446-e054-00144ff8d46c2026-06-04WarningsExact identifier
unii: 15FIX9V2JP
VitaPhyte Redness Reliever Lubricant Eye DropsREDNESS RELIEVER LUBRICANT EYE DROPSGuangzhou Liyan Cosmetics Technology Co., Ltd.53d4e9b0-c9a0-797a-e063-6294a90ad0cf2026-06-04WarningsExact identifier
unii: B697894SGQ
ANESSA PERFECT UV SUNSCREEN SKINCARE MILK GBZINC OXIDE OCTOCRYLENE ETHYLHEXYL SALICYLATE HOMOSALATE TITANIUM DIOXIDEHONGKONG JIAHE INTERNATIONAL HOLDING LIMITED5354af18-50c4-5fba-e063-6394a90ace392026-06-03WarningsExact identifier
unii: 15FIX9V2JP
OlanzapineOLANZAPINEREMEDYREPACK INC.032e589c-47b1-4eb1-9466-8160297b81e92026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
Rohto Digi-EyeHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDEThe Mentholatum Company5d6f37b9-b568-4cb6-92de-eb40779f3f8c2026-06-03WarningsExact identifier
unii: 3NXW29V3WO
ATOMY BB SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.b0cd27ee-4917-4800-bcdf-c6e14b28c1d12026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Atomy Sunscreen White Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.ad0b9091-a990-45bf-93f4-d886be1bbffe2026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.994d5680-284e-4faf-a29b-4d28f8d46e8f2026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Matte Veil Tinted Broad Spectrum Sunscreen SPF 40ZINC OXIDE, TITANIUM DIOXIDEPrivate Label Skin Carea8d60212-18a7-42af-8bb3-bfcff7690a492026-06-02WarningsExact identifier
unii: 15FIX9V2JP
The Mineral Melt SPF30ZINC OXIDE, TITANIUM DIOXIDEDune Suncare Inc.2114fc3b-c8ce-45d2-8a82-4dc54f0adaf32026-06-02WarningsExact identifier
unii: 15FIX9V2JP
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS UV AIR MINERAL SERUM SUNSCREEN BROAD SPECTRUM SPF 50TITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inca1acb789-5bf4-4447-b3c5-4a7d4d3013a72026-06-01WarningsExact identifier
unii: 15FIX9V2JP
Visine Red Eye Hydrating Comfort Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Savings Distributors LLC558178eb-1eec-af0f-e063-6394a90afad92026-06-01WarningsExact identifier
unii: B697894SGQ
OlanzapineOLANZAPINEAurobindo Pharma Limited4d768cfe-3b20-4127-95b9-b4151b28afcc2026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN MINER ALL UV SERUM BROAD SPECTRUM SPF 50 PLUS MINERAL SUNSCREENTITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc294e6049-12b5-4b45-ae00-8ee1d9d2a1a42026-05-29WarningsExact identifier
unii: 15FIX9V2JP
Blink Triple Care Preservative FreePOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporated65e67990-78b7-4ce9-963b-6bed3a6bed072026-05-27WarningsExact identifier
unii: B697894SGQ
OlanzapineOLANZAPINECoupler LLC52b99337-afa8-a6f9-e063-6294a90a20382026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREENOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H Co., Ltd.52ba9423-8b9b-38f7-e063-6394a90a95da2026-05-26WarningsExact identifier
unii: 15FIX9V2JP
OlanzapineOLANZAPINECoupler LLC52bdaaaf-ab54-99d1-e063-6394a90a521f2026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR

Reported adverse events (FAERS/openFDA)#

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