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 7 of 7 · 134 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OlanzapineOLANZAPINELannett Company, Inc.002dd00f-7946-ea4f-e063-6294a90a59162023-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312076
unii: N7U69T4SZR
Theraworx Relief for Foot Cramps FoamMAGNESIUM SULFATE, UNSPECIFIED FORMAVADIM HOLDINGS, INC.2f7fe6b7-deb0-4bf7-a8cb-15ae468512da2023-04-25WarningsExact identifier
unii: DE08037SAB
OlanzapineOLANZAPINEBryant Ranch Prepack09e48e71-4dd2-4538-91d7-5b284f6647d82023-03-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEProficient Rx LPce66d545-015b-41d5-80c3-964d78e36bfd2023-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
Concept DHAVITAMIN- MINERAL OMEGA-3 SUPPLEMENTU.S. Pharmaceutical Corporationbd2051f7-b887-46f6-8d4a-b099fcd086292022-11-08WarningsExact identifier
unii: DE08037SAB
Concept OBVITAMIN MINERAL SUPPLEMENTU.S. Pharmaceutical Corporation37992a25-68bd-4050-b936-596ddedc25a32022-11-08Warnings, Adverse reactionsExact identifier
unii: DE08037SAB
OlanzapineOLANZAPINEDr. Reddy's Laboratories Ltd.9a57a63e-f856-aafa-037a-c08f2fea64962022-10-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEProficient Rx LP1f4a2eaf-3a12-4ebe-b97f-0a7bfbc325722022-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
d29c0ad5-8599-40b4-983c-95028557cd31d974d2a4-fc65-42ff-8138-cfcfd73815342021-07-27Warnings, Adverse reactionsExact identifier
spl set id: d974d2a4-fc65-42ff-8138-cfcfd7381534
77d3d923-8571-4523-8e69-234ebeb7a5fd8ff9fc66-8367-445b-bb35-f6b112543d362021-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 77d3d923-8571-4523-8e69-234ebeb7a5fd
spl set id: 8ff9fc66-8367-445b-bb35-f6b112543d36
OlanzapineOLANZAPINEProficient Rx LPe40d54bf-7334-4418-8a87-ff85941adec12021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEProficient Rx LP61424fa3-b09a-4267-a208-a7c7c3f69fe52020-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEAphena Pharma Solutions - Tennessee, LLCb6ec5610-b4a6-4646-954a-0fe8b1d3e1432020-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEProficient Rx LP7772a4c2-1fb1-412b-9e3b-ef3d693517a22019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR

Reported adverse events (FAERS/openFDA)#

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