FDA.reportPublic FDA data

NDC 49884-322-52 - 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
49884-322
Requested NDC
49884-322-52
Package NDCs from labels
49884-322-52, 49884-322-55
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
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
49884-322-52EA - Each49884-322fd652ce9-0229-4f8f-975c-8e7fc992bc7512013-02-13
49884-322-55EA - Each49884-32261e78589-b59b-47b9-ba67-d6fd07c7348a12012-07-24

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 1 of 8 · 144 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OlanzapineOLANZAPINECoupler LLC5af81f87-5582-aa23-e063-6294a90a1ee82026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEHikma Pharmaceuticals USA Inc.63bcfe98-d1fc-4cd7-9212-f59ee4dcc6d12026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEREMEDYREPACK INC.c47ee16f-5a86-49f2-8d85-5f49a6c8d91e2026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINECardinal Health 107, LLC38a89689-efc2-4931-8f65-868dc0248d6a2026-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
Sodium Sulfate, Potassium Sulfate and Magnesium SulfateSODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATEAscend Laboratories, LLC2106d1aa-086e-4248-9a3d-ec138d492cf32026-08-08Warnings, Adverse reactionsExact identifier
unii: DE08037SAB
OlanzapineOLANZAPINEPreferred Pharmaceuticals Inc.d349d5b7-5658-46d6-9bba-e6f6361cebb92026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEPreferred Pharmaceuticals Inc.5bded04a-d848-4ac6-b7c3-ff9b9fef3d292026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
WinCo Pure 5lbPURE 5LB EPSOM SALTWinCo Foods, LLC58529382-a192-cda2-e063-6394a90adb692026-08-05WarningsExact identifier
unii: DE08037SAB
OlanzapineOLANZAPINEMajor Pharmaceuticals709d79a1-2742-4629-af43-161be166833a2026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEREMEDYREPACK INC.9eb6b0d1-b301-4847-88f5-f8613d550ecc2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEPD-Rx Pharmaceuticals, Inc.b6f0b2e2-3cbd-4564-8b3e-f811589af2752026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEREMEDYREPACK INC.3d69af75-7615-4ec2-b7ef-467b2558c5c82026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEDr. Reddy's Laboratories Ltd.a4c525da-c2f6-b804-af49-6012959222542026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEREMEDYREPACK INC.ad350abc-a1fc-4be4-b2be-c629121552a02026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEREMEDYREPACK INC.b513823d-927c-4111-8766-e6c37f84b2212026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEREMEDYREPACK INC.68de2a51-69b2-4d99-be79-36a95a4bc4752026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEMajor Pharmaceuticals0ecbf540-572e-4ca4-b694-18ca1cd1c1942026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEREMEDYREPACK INC.1705bab2-a2f8-4534-b1fc-eb309cd2696b2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINECamber Pharmaceuticals, Inc.c1387008-6dc4-4f1e-ae29-fa7a0f0be6842026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEREMEDYREPACK INC.8e5ef52d-315b-4055-9e52-403e6f896f242026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR

Reported adverse events (FAERS/openFDA)#

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