FDA.reportPublic FDA data

NDC 49884-321-52 - 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
49884-321
Requested NDC
49884-321-52
Package NDCs from labels
49884-321-52, 49884-321-55
Manufacturer
Par Pharmaceutical, Inc.
Effective date
2021-07-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Olanzapine - Par Pharmaceutical, Inc.Par Pharmaceutical, Inc.2021-07-27HUMAN PRESCRIPTION DRUG LABEL
Olanzapine - A-S Medication SolutionsA-S Medication Solutions2021-06-16HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-321-52EA - Each49884-32124ba7eaa-da74-4286-869e-a9d794c4737a12013-02-13
49884-321-55EA - Each49884-321c3e092d2-7419-4730-bc87-21186002ad8912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OLANZAPINEACTIVE INGREDIENTN7U69T4SZROLANZAPINE TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL, INC.]3
OLANZAPINEACTIVE MOIETYN7U69T4SZROLANZAPINE TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL, INC.]3
MAGNESIUM SULFATE, UNSPECIFIEDINACTIVE INGREDIENTDE08037SABOLANZAPINE TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL, INC.]3

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 7 · 134 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OlanzapineOLANZAPINEModavar Pharmaceuticals LLCf0943b4e-6bdc-48c1-8ecd-39cf732e16f52026-04-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
Olanzapine and FluoxetineOLANZAPINE AND FLUOXETINETeva Pharmaceuticals USA, Inc.3c28cf18-01a3-468a-ab3e-8aa82f9182512026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEXGen Pharmaceuticals DJB, Inc.3aad0f7b-8d0c-a9bf-e063-6394a90a6ae82026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEStrides Pharma Science Limited979c3212-36e8-4287-aace-bef0875188d72026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078109
rxcui: 312076
unii: N7U69T4SZR
OlanzapineOLANZAPINEREMEDYREPACK INC.76a6ff21-7157-4213-8073-35837a3ac07e2026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
Olanzapine IntramuscularOLANZAPINEUBI Pharma Inc.6a279fe1-ed99-4a62-b2c7-831961470fa92026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEHEC Pharm USA Inc.4d1b83db-54db-d51f-e063-6394a90a4a692026-03-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312076
unii: N7U69T4SZR
OLANZAPINEOLANZAPINEHEC Pharm USA Inc.4d34f8f3-edc8-0a68-e063-6394a90a9c1f2026-03-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate OralSODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE ORALStrides Pharma Science Limitedd48d8c59-68b9-4e28-86a4-eabf8b2003b02026-03-10Warnings, Adverse reactionsExact identifier
unii: DE08037SAB
OlanzapineOLANZAPINEDr.Reddy's Laboratories Limitedaff02cff-d079-bc82-6182-a24c4c6e09a62026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312076
unii: N7U69T4SZR
OlanzapineOLANZAPINEDr. Reddy's Laboratories Inc.d474d5a9-d338-511d-5823-567c0a1bbf4d2026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
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
unii: N7U69T4SZR
OlanzapineOLANZAPINEMacleods Pharmaceuticals Limiteddf43938a-3469-40eb-8166-f0a2fd29d6d82026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312076
unii: N7U69T4SZR
OLANZAPINEOLANZAPINETorrent Pharmaceuticals Limited2cb1bebe-0ced-46d8-bf21-c28a9acc4a152026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312076
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
rxcui: 312076
unii: N7U69T4SZR
OlanzapineOLANZAPINESandoz Incc44a96cc-817d-4eb5-a13a-00977f76e6662026-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEAmerican Health Packagingc0d705bf-b719-4c7b-b83d-c17d41cbbfad2026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINESandoz Inc1e9666ef-4271-4834-8496-ccb3125d83db2026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR

Reported adverse events (FAERS/openFDA)#

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