NDC 72303-0844-01 - 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
72303-0844
Requested NDC
72303-0844-01
Package NDCs from labels
72303-0844-1, 72303-0844-01
Manufacturer
HEC Pharm USA Inc. | Sunshine Lake Pharma Co., Ltd.
Effective date
2026-03-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Olanzapine - HEC Pharm USA Inc. | Sunshine Lake Pharma Co., Ltd.HEC Pharm USA Inc. | Sunshine Lake Pharma Co., Ltd.2026-03-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72303-0844-1Olanzapine30 in 1 BOTTLE, PLASTICTABLET, ORALLY DISINTEGRATING301

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 3 of 7 · 122 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OlanzapineOLANZAPINEREMEDYREPACK INC.76a6ff21-7157-4213-8073-35837a3ac07e2026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
Olanzapine IntramuscularOLANZAPINEUBI Pharma Inc.6a279fe1-ed99-4a62-b2c7-831961470fa92026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEHEC Pharm USA Inc.4d1b83db-54db-d51f-e063-6394a90a4a692026-03-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA208146
ndc (package): 72303-0842-1
ndc (package): 72303-0841-1
ndc (package): 72303-0844-1
ndc (package): 72303-0843-1
ndc (product): 72303-0841
ndc (product): 72303-0844
ndc (product): 72303-0843
ndc (product): 72303-0842
ndc11 (package): 72303084401
rxcui: 312076
rxcui: 351108
rxcui: 351107
rxcui: 314155
spl id: 4d1b8476-a9ab-067a-e063-6294a90a57c0
spl set id: 4d1b83db-54db-d51f-e063-6394a90a4a69
unii: N7U69T4SZR
OLANZAPINEOLANZAPINEHEC Pharm USA Inc.4d34f8f3-edc8-0a68-e063-6394a90a9c1f2026-03-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEDr.Reddy's Laboratories Limitedaff02cff-d079-bc82-6182-a24c4c6e09a62026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312076
rxcui: 351108
rxcui: 351107
rxcui: 314155
unii: N7U69T4SZR
OlanzapineOLANZAPINEDr. Reddy's Laboratories Inc.d474d5a9-d338-511d-5823-567c0a1bbf4d2026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OLANZAPINEOLANZAPINEAnthea Pharma Private Limitede6ffcc56-63f9-4b12-a07a-c6177ffef5e82026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEMacleods Pharmaceuticals Limited8e095987-bdea-42f2-9550-c7155cf07d302026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEMacleods Pharmaceuticals Limiteddf43938a-3469-40eb-8166-f0a2fd29d6d82026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312076
rxcui: 351108
rxcui: 351107
rxcui: 314155
unii: N7U69T4SZR
OLANZAPINEOLANZAPINETorrent Pharmaceuticals Limited2cb1bebe-0ced-46d8-bf21-c28a9acc4a152026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312076
rxcui: 351108
rxcui: 351107
rxcui: 314155
unii: N7U69T4SZR
OlanzapineOLANZAPINEAmerican Regent, Inc.e9ac2bd3-dbff-4b1a-952f-da3909c6e4ee2026-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINETeva Pharmaceuticals USA, Inc.dd0b2525-4e2f-44fc-9302-0ae4ebb1e1352026-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312076
rxcui: 351108
rxcui: 351107
rxcui: 314155
unii: N7U69T4SZR
OlanzapineOLANZAPINESandoz Incc44a96cc-817d-4eb5-a13a-00977f76e6662026-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEAmerican Health Packagingc0d705bf-b719-4c7b-b83d-c17d41cbbfad2026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINESandoz Inc1e9666ef-4271-4834-8496-ccb3125d83db2026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
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
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
Artificial Sweetener Detox 6034ARTIFICIAL SWEETENER DETOXProfessional Complementary Health Formulas38f2ae0b-2b1f-4b49-934d-fe1556f84d932026-01-08WarningsExact identifier
unii: Z0H242BBR1

Reported adverse events (FAERS/openFDA)#

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