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 4 of 7 · 134 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OLANZAPINEOLANZAPINEEugia US LLC9c745e2e-89d3-44d4-906e-704705c333102026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEAurobindo Pharma Limited636665be-9d7e-443a-8134-e8cc47e6ba242026-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
Epsom SaltEPSOM SALTEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)1845ea0c-0cb6-482b-abe6-fa17785c5b902026-02-09WarningsExact identifier
unii: DE08037SAB
Epsom SaltMAGNESIUM SULFATESam's West, Inc6edb7688-0a64-4a7e-a0c0-9f75c96682fe2026-02-03WarningsExact identifier
unii: DE08037SAB
LYBALVIOLANZAPINE AND SAMIDORPHAN L-MALATEAlkermes, Inc.32ffddd1-4e2b-45d9-9b36-bb730167ec802026-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
SUPREP Bowel PrepSODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATEAzurity Pharmaceuticals, Inc.50f23abd-6a66-44cb-960e-d43c16a5ae5f2026-01-31Warnings, Adverse reactionsExact identifier
unii: DE08037SAB
OlanzapineOLANZAPINECoupler LLC495efc49-7cdb-4b9e-e063-6394a90a547e2026-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
ROYAL Epsom SaltMAGNESIUM SULFATEFilo America40eb04d2-fcc9-4ee2-8483-99699ea7e3862026-01-22WarningsExact identifier
unii: DE08037SAB
Cramp911MAGNESIUM SULFATE, COPPER SULFATEDelCorean, LLC47b59658-f4ba-45cb-e054-00144ff88e882026-01-13WarningsExact identifier
unii: DE08037SAB
Cramp911MAGNESIUM SULFATE, COPPER SULFATEDelCorean, LLC481f5af0-deb4-5bd3-e054-00144ff8d46c2026-01-13WarningsExact identifier
unii: DE08037SAB
Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Bowel Prep kitSODIUM SULFATE ANHYDROUS, POTASSIUM SULFATE, AND MAGNESIUM SULFATESun Pharmaceutical Industries, Inc.4adeeb11-0f3a-47d8-a664-376df50b05f22025-12-31Warnings, Adverse reactionsExact identifier
unii: DE08037SAB
OlanzapineOLANZAPINEAscend Laboratories, LLCe8626e68-088d-47ff-bf06-489a778815aa2025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
Olanzapine and FluoxetineOLANZAPINE AND FUOXETINEPar Health USA, LLC2f6ceda3-3edc-4427-98a6-23e3c930c44d2025-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEApotex Corp.3347d1c8-04c9-5ce1-8cda-b38e0412b7092025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
Berberis ViscumBERBERIS VISCUMUriel Pharmacy Inc.30abbbd6-1657-4959-9f07-85ddf45f11192025-11-14WarningsExact identifier
unii: DE08037SAB
OlanzapineOLANZAPINECoupler LLC42d9ad47-52cc-ad11-e063-6394a90aedca2025-11-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEQilu Pharmaceutical Co., Ltd.12ce860a-6f22-4db6-8acf-786b40f5a5a52025-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEAmerican Health Packaging75616c31-8fed-4014-a9f2-4a028eccd5862025-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
Olanzapine and FluoxetineOLANZAPINE AND FLUOXETINEAvKAREf5f78ed2-4640-8528-c51c-d7bffa045d482025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINECoupler LLC40187874-447a-de20-e063-6394a90aafe72025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR

Reported adverse events (FAERS/openFDA)#

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