NDC 43598-166-79 - 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
43598-166
Requested NDC
43598-166-79
Package NDCs from labels
43598-166-30, 43598-166-60, 43598-166-01, 43598-166-05, 43598-166-10, 43598-166-79, 43598-166-78
Manufacturer
REMEDYREPACK INC.
Effective date
2026-09-21
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.2026-09-21HUMAN PRESCRIPTION DRUG LABEL
Olanzapine - Major PharmaceuticalsMajor Pharmaceuticals2026-07-08HUMAN PRESCRIPTION DRUG LABEL
Olanzapine - REMEDYREPACK INC.REMEDYREPACK INC.2026-07-08HUMAN PRESCRIPTION DRUG LABEL
Olanzapine - Unit Dose Solutions, Inc.Unit Dose Solutions, Inc.2026-06-29HUMAN PRESCRIPTION DRUG LABEL
Olanzapine - Dr. Reddy's Laboratories Inc. | Dr.Reddy's Laboratories Limited-FTO3Dr. Reddy's Laboratories Inc. | Dr.Reddy's Laboratories Limited-FTO32026-03-09HUMAN PRESCRIPTION DRUG LABEL
Olanzapine - American Health PackagingAmerican Health Packaging2025-10-20HUMAN PRESCRIPTION DRUG LABEL
Olanzapine - Bryant Ranch PrepackBryant Ranch Prepack2025-06-02HUMAN PRESCRIPTION DRUG LABEL
Olanzapine - Quality Care Products, LLCQuality Care Products, LLC2022-10-26HUMAN PRESCRIPTION DRUG LABEL
Olanzapine - A-S Medication SolutionsA-S Medication Solutions2020-07-24HUMAN PRESCRIPTION DRUG LABEL
Olanzapine - A-S Medication SolutionsA-S Medication Solutions2018-08-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-166-01Olanzapine100 in 1 BOTTLETABLET, FILM COATED10013
43598-166-05Olanzapine500 in 1 BOTTLETABLET, FILM COATED50013
43598-166-10Olanzapine1000 in 1 BOTTLETABLET, FILM COATED100013
43598-166-30Olanzapine30 in 1 BOTTLETABLET, FILM COATED3013
43598-166-60Olanzapine60 in 1 BOTTLETABLET, FILM COATED6013
43598-166-78Olanzapine10 in 1 CARTONTABLET, FILM COATED1013
43598-166-79Olanzapine10 in 1 BLISTER PACKTABLET, FILM COATED1013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-166OLANZAPINE TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC.]13Current NDC, Legacy NDC, 7 package rows20250429_d474d5a9-d338-511d-5823-567c0a1bbf4d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-166-05EA - Each43598-1663a6eaa44-fdcd-4ea7-b378-d7738a634c9e12014-02-04
43598-166-30EA - Each43598-1665acb32e2-8948-40ed-a1eb-8bb877d12f3c12014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OLANZAPINEACTIVE INGREDIENTN7U69T4SZROLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]7
OLANZAPINEACTIVE MOIETYN7U69T4SZROLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]7
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]7
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671POLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]7
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQOLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]7
olanzapineACTIVE INGREDIENTN7U69T4SZROLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC]4
olanzapineACTIVE INGREDIENTN7U69T4SZROLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
OLANZAPINEACTIVE MOIETYN7U69T4SZROLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC]4
OLANZAPINEACTIVE MOIETYN7U69T4SZROLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
CrospovidoneINACTIVE INGREDIENT68401960MKOLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC]4
CrospovidoneINACTIVE INGREDIENT68401960MKOLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKOLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKOLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671POLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
Hydroxypropyl Cellulose (Type H)INACTIVE INGREDIENTRFW2ET671POLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC]4
hypromellosesINACTIVE INGREDIENT3NXW29V3WOOLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
hypromellosesINACTIVE INGREDIENT3NXW29V3WOOLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC]4
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XOLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC]4
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XOLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
magnesium stearateINACTIVE INGREDIENT70097M6I30OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
magnesium stearateINACTIVE INGREDIENT70097M6I30OLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQOLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQOLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPOLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC]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 67 of 111 · 2,218 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Solar SPF 40 Broad Spectrum SPF 40 Water Resistant (80 min) Mineral SuncreenTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences6ce602bb-c1f4-43c1-ae61-0f05d7952db32025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Solar stick Tinted SPF 40 Tinted Broad Spectrum SPF 40 Water Resistant (80 min) Mineral SuncreenTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciencesb8f08778-7e5e-4341-9a24-1ce57c6525c72025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Nemah SPF 30 Mineral C/S Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDENemah, Inc.36da2d94-fa90-b145-e063-6394a90a58542025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Mineral KidStick SPF 40 Mineral Broad Spectrum SPF 40 Sunscreen UVA-UVB SuncreenTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences4c7f0257-fa12-40d6-9516-824b0e3a182c2025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Mineral KidCreme SPF 50TITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences9ec56c68-6fea-444b-aeed-0b5d60c42e752025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Aveeno Calm Plus Restore Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLCfbf8be03-93e2-4d7e-e053-6294a90a4fd52025-06-04WarningsExact identifier
unii: 15FIX9V2JP
Age Defense for Eyes 5 in 1ZINC OXIDE AND TITANIUM DIOXIDETopiderm, Inc.48d5343a-1068-4c64-a275-c180026d69472025-06-03WarningsExact identifier
unii: 15FIX9V2JP
OlanzapineOLANZAPINEBryant Ranch Prepack3c9963b1-c498-48a0-a3a1-1eaa6a1028fc2025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076255
ndc (package): 71335-2627-3
ndc (package): 71335-2627-1
ndc (package): 71335-2627-2
ndc (product): 71335-2627
rxcui: 314154
spl id: bdb8dfd3-6c84-491b-962b-becf607b42f0
spl set id: 3c9963b1-c498-48a0-a3a1-1eaa6a1028fc
unii: N7U69T4SZR
Bluevado SunfixZINC OXIDE, TITANIUM DIOXIDEMagic Blue, LLC31f1e961-3719-f70a-e063-6394a90a481e2025-05-31WarningsExact identifier
unii: 15FIX9V2JP
Dr. Mercola Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDENatural Health Partners, LLC47f6ab9e-fa73-496a-e054-00144ff8d46c2025-05-28WarningsExact identifier
unii: 15FIX9V2JP
Protect Daily Ritual Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35ce8307-387b-2b40-e063-6294a90a28bc2025-05-23Exact identifier
unii: 15FIX9V2JP
Insecticides/Pest/Food Additives DetoxBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDr. Donna Restivo DCb5778211-0e3e-44ef-bd65-a76a68cf15042025-05-23WarningsExact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35bea4f3-c19e-3e2e-e063-6394a90aeb692025-05-22Exact identifier
unii: 15FIX9V2JP
OlanzapineOLANZAPINEBryant Ranch Prepackf6fd7ceb-1457-4c3e-9d30-4f658f39d37d2025-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314154
unii: N7U69T4SZR
Mineral Stick Non-TintedTITANIUM DIOXIDE, ZINC OXIDEIT INTELLIGENT TREATMENT LLC3595149d-0735-6bea-e063-6394a90a618a2025-05-20Exact identifier
unii: 15FIX9V2JP
Mineral Stick TintedTITANIUM DIOXIDE, ZINC OXIDEIT INTELLIGENT TREATMENT LLC3595735e-c25f-eb48-e063-6294a90aac0f2025-05-20Exact identifier
unii: 15FIX9V2JP
OlanzapineOLANZAPINEBryant Ranch Prepackc47f90fc-49fe-4f60-9da8-1365a1650dd92025-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314154
unii: N7U69T4SZR
OlanzapineOLANZAPINEBryant Ranch Prepackdcf8fcbf-636c-41ad-8084-c65ac2f117cc2025-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200034
unii: N7U69T4SZR
Bright Guard Sport SPFZINC SPFRENU LABORATORIES, LLCc9b48a9e-d69f-65a7-e053-2995a90a0baf2025-05-12WarningsExact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b6aa46-657b-2676-e063-6294a90abadd2025-05-09Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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