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 5 of 7 · 134 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OlanzapineOLANZAPINECoupler LLC3ed78a7d-4014-d280-e063-6294a90a8ee92025-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEPreferred Pharmaceuticals Inc.cfc0f187-d3ff-4bbb-9129-0e94c6eda0ee2025-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
Epsom SaltEPSOM SALTStrategic Sourcing Services LLC1515fadd-a7a5-4502-afe2-cfcd50d5bfc82025-07-11WarningsExact identifier
unii: DE08037SAB
Olanzapine IntramuscularOLANZAPINEPAI Holdings, LLC dba PAI Pharma9d9f25d5-4513-434a-a37a-392a0c978f2e2025-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
Epsom SaltMAGNESIUM SULFATEChain Drug Consortium, LLCc9807e6e-9dcc-41a2-8956-b61623ac21762025-06-27WarningsExact identifier
unii: DE08037SAB
OlanzapineOLANZAPINECoupler LLC37c88965-c51d-946d-e063-6394a90a012c2025-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312076
unii: N7U69T4SZR
OlanzapineOLANZAPINEBryant Ranch Prepack1866a03c-eac9-44a1-8f33-7dc6e8a8c06a2025-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEBryant Ranch Prepack3c9963b1-c498-48a0-a3a1-1eaa6a1028fc2025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEBryant Ranch Prepackf6fd7ceb-1457-4c3e-9d30-4f658f39d37d2025-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEBryant Ranch Prepackc47f90fc-49fe-4f60-9da8-1365a1650dd92025-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
MARS WELLNESS MAGNESIUMMENTHOLRENU LABORATORIES, LLCdae7673c-4352-b9d7-e053-2995a90a96da2025-05-14WarningsExact identifier
unii: DE08037SAB
OlanzapineOLANZAPINEBryant Ranch Prepackdcf8fcbf-636c-41ad-8084-c65ac2f117cc2025-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
Magnesium sulf. BryoniaMAGNESIUM SULF. BRYONIAUriel Pharmacy Inc.9418bb05-afd1-fc80-e053-2a95a90a33a22025-04-30WarningsExact identifier
unii: DE08037SAB
OlanzapineOLANZAPINEBryant Ranch Prepack8586e828-34e7-4eb4-a933-6c688927478f2025-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEBryant Ranch Prepackd5a9f78e-56f4-4249-800c-5f52a99fa84b2025-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEBryant Ranch Prepackd3857220-d9ff-4820-bf53-f2384b59a1a62025-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEBryant Ranch Prepacked93d6b9-912a-444a-a695-439d0bfb877a2025-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312076
unii: N7U69T4SZR
OlanzapineOLANZAPINEGolden State Medical Supply, Inc.9847a0e4-24fc-f4e8-e053-2995a90a961e2025-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312076
unii: N7U69T4SZR
Epsom SaltMAGNESIUM SULFATEStrategic Sourcing Services LLC99aa30ed-9659-4f60-a31d-6aaf09909b512025-04-14WarningsExact identifier
unii: DE08037SAB
OlanzapineOLANZAPINECoupler LLC325d5d69-5133-79ea-e063-6294a90afdd02025-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR

Reported adverse events (FAERS/openFDA)#

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