FDA.reportPublic FDA data

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 44 of 111 · 2,218 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Matte Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESkin Philosophy by Kelly3581cf33-3520-42f7-e063-6394a90a6f932025-12-12Exact identifier
unii: 15FIX9V2JP
Matte Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESkin Philosophy by Kelly3592b2c7-295a-7c60-e063-6394a90a387b2025-12-12Exact identifier
unii: 15FIX9V2JP
Sun Elegant Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDESKIN BY NESRIN3580ae10-1867-cb68-e063-6394a90a72df2025-12-12Exact identifier
unii: 15FIX9V2JP
PROTECTOR SOLAR NON-TINTED SPF SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEThe Beez Kneez Skin Care & Acne Clinic LLC358195c0-6d28-1ffe-e063-6394a90a60272025-12-12Exact identifier
unii: 15FIX9V2JP
Matte Velvet TintTITANIUM DIOXIDE, ZINC OXIDEBrent Loftis, D.O., Inc., A California Medical Corporation3583f860-664b-2658-e063-6394a90a38572025-12-12Exact identifier
unii: 15FIX9V2JP
SPF LipTITANIUM DIOXIDE, ZINC OXIDEBrent Loftis, D.O., Inc., A California Medical Corporation359297cd-10e2-6ddd-e063-6394a90a4aa02025-12-12Exact identifier
unii: 15FIX9V2JP
Matte Velvet TintTITANIUM DIOXIDE, ZINC OXIDEBrent Loftis, D.O., Inc., A California Medical Corporation359641c5-0e19-f243-e063-6394a90aeebc2025-12-12Exact identifier
unii: 15FIX9V2JP
TINTED MINERAL SUNSCREEN SPF 40TITANIUM DIOXIDE, ZINC OXIDEDERMATOLOGY ARTS35814d5d-fd34-05b3-e063-6294a90aadd12025-12-12Exact identifier
unii: 15FIX9V2JP
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELA HAIR DESIGN36eb4cd3-778c-362f-e063-6294a90a059c2025-12-11Exact identifier
unii: 15FIX9V2JP
Matte FinishTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC37630c6c-f768-7b3e-e063-6394a90af5652025-12-11Exact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEADVANCED AESTHETICS SKIN CARE STUDIO, INC348fcc63-d8e3-90a1-e063-6294a90ade112025-12-11Exact identifier
unii: 15FIX9V2JP
SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique Aesthetics Pllc34a49563-c74b-2fd1-e063-6394a90a6c562025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a52011-b781-75cf-e063-6394a90ae0f42025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a632f5-4458-e335-e063-6394a90a9bcb2025-12-11Exact identifier
unii: 15FIX9V2JP
Matte FinishTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC3761d74c-0137-0c75-e063-6394a90a3c7d2025-12-11Exact identifier
unii: 15FIX9V2JP
Sun Plus Sun Lip ShieldTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC3763a79a-e881-cade-e063-6394a90a49de2025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Minerals 1point8 ozTITANIUM DIOXIDE, ZINC OXIDESPECKTRA6 LLC374e53c6-307f-f8e5-e063-6394a90a07ef2025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Minerals 1point8 ozTITANIUM DIOXIDE, ZINC OXIDESPECKTRA6 LLC373e29f1-d665-a3c4-e063-6294a90a403e2025-12-11Exact identifier
unii: 15FIX9V2JP
Defend Tinted Mineral SPF 40TITANIUM DIOXIDE, ZINC OXIDESMOOTH ESTHETICS LLC36eb9fc0-25d7-cfb4-e063-6394a90a2e222025-12-11Exact identifier
unii: 15FIX9V2JP
Sheer Tinted Sunscreen SPF40TITANIUM DIOXIDE, ZINC OXIDESIMPLICITY SKIN, SPA & BOUTIQUE, LLC36ebdb85-ce8a-d7e0-e063-6394a90a22612025-12-11Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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