FDA.reportPublic FDA data

NDC 67184-0573-01 - 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
67184-0573
Requested NDC
67184-0573-01
Package NDCs from labels
67184-0573-1, 67184-0573-01
Manufacturer
Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical Co., Ltd. (Biological Industrial Park)
Effective date
2025-10-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Olanzapine - Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical Co., Ltd. (Biological Industrial Park)Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical Co., Ltd. (Biological Industrial Park)2025-10-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67184-0573-1Olanzapine2 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION21
67184-0573-1Olanzapine1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION11

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 · 133 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OlanzapineOLANZAPINEAurobindo Pharma Limited636665be-9d7e-443a-8134-e8cc47e6ba242026-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
LYBALVIOLANZAPINE AND SAMIDORPHAN L-MALATEAlkermes, Inc.32ffddd1-4e2b-45d9-9b36-bb730167ec802026-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINECoupler LLC495efc49-7cdb-4b9e-e063-6394a90a547e2026-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
Endotoxin Terrain Drops 2143ENDOTOXIN TERRAIN DROPSProfessional Complementary Health Formulas58842566-005a-48b5-973d-20cde2fbd7012026-01-08WarningsExact identifier
unii: QTT17582CB
Abdominal Pain Drops 2051ABDOMINAL PAIN DROPSProfessional Complementary Health Formulasf1b1dde6-bb37-4774-a58c-b4f648f9c2b52026-01-08WarningsExact identifier
unii: QTT17582CB
OlanzapineOLANZAPINEAscend Laboratories, LLCe8626e68-088d-47ff-bf06-489a778815aa2025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
HemorrhoidAESCULUS HIPP, HAMAMELIS, ALOE, CALC PHOS, CARBO AN, CARBO VEG, LACHESIS, LYCOPODIUM, MURIATICUM AC, NITRICUM AC, NUX VOM, PAEONIA, RATANHIA, SEPIA, SULPHURNatural Creations, Incdb1b3aef-ba92-417c-b6f6-58e950ed42142025-12-16WarningsExact identifier
unii: QTT17582CB
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
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
application number: ANDA218116
ndc (package): 67184-0573-1
ndc (product): 67184-0573
ndc11 (package): 67184057301
rxcui: 485968
spl id: 816c3bbf-aa02-47e2-88d2-3a50c7764a84
spl set id: 12ce860a-6f22-4db6-8acf-786b40f5a5a5
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
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
Aller-Chord FACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE.Energetix Corporationff4eb7b2-8272-4bd3-99a9-7e589b30d59a2025-07-15WarningsExact identifier
unii: W4888I119H
Olanzapine IntramuscularOLANZAPINEPAI Holdings, LLC dba PAI Pharma9d9f25d5-4513-434a-a37a-392a0c978f2e2025-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485968
unii: N7U69T4SZR
OlanzapineOLANZAPINECoupler LLC37c88965-c51d-946d-e063-6394a90a012c2025-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEBryant Ranch Prepack1866a03c-eac9-44a1-8f33-7dc6e8a8c06a2025-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR

Reported adverse events (FAERS/openFDA)#

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