FDA.reportPublic FDA data

NDC 72303-0835-01 - 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
72303-0835
Requested NDC
72303-0835-01
Package NDCs from labels
72303-0835-1, 72303-0835-01
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
72303-0835-1OLANZAPINE30 in 1 BOTTLE, PLASTICTABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72303-0835-1EA - Each72303-0835cbcbe9cf-9ff0-4327-bbc2-59352f20562a12026-05-22

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 14 of 113 · 2,251 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunscreen SPF 50SUNSCREEN SPF 50Guangzhou Ariel Biotech Co., Ltd.4dd05620-30a3-9cea-e063-6294a90af18b2026-03-24WarningsExact identifier
unii: 15FIX9V2JP
Sunscreen SPF 50SUNSCREEN SPF 50Guangzhou Ariel Biotech Co., Ltd.4dd1b722-4448-9675-e063-6294a90a5f4f2026-03-24WarningsExact identifier
unii: 15FIX9V2JP
WHAMISA ORGANIC PEAR BLOSSOM SUNSCREENZINC OXIDEENS KOREA Co., Ltd.34f9688d-efa1-1d3f-e063-6294a90ab1272026-03-23WarningsExact identifier
unii: 15FIX9V2JP
HALORINNA SUN-SCREEN TRAVEL SPF50SUN SCREENGuangdong Bisutang Biotechnology Co., LTD4dade579-ce77-eea5-e063-6394a90ad46a2026-03-23WarningsExact identifier
unii: 15FIX9V2JP
Olanzapine IntramuscularOLANZAPINEUBI Pharma Inc.6a279fe1-ed99-4a62-b2c7-831961470fa92026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
BLINK TRIPLE CAREPOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporateda2b34eb0-001b-4f42-a8cc-c2a0150fafcc2026-03-20WarningsExact identifier
unii: B697894SGQ
Protect by HEALTHY SKIN LAB MD SUNSCREEN TINTED MOISTURIZERTITANIUM DIOXIDE, ZINC OXIDEHEALTHY SKIN LAB LIMITED4a1ec566-549f-45f2-a43d-dacfc72633612026-03-20WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30SKNVcare, LLC4d67dfb4-3607-2af6-e063-6294a90ae01a2026-03-19WarningsExact identifier
unii: 15FIX9V2JP
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Premier Plastic Surgery4d3a36b9-7d60-01ac-e063-6294a90af4fb2026-03-18WarningsExact identifier
unii: 15FIX9V2JP
OSKIN New York Coffee BB Cream SPF 30TITANIUM DIOXIDE, OCTOCRYLENE, ZINC OXIDEO'Skin Studio NY29dae75a-4368-432a-9cf8-f0f021f09e292026-03-17WarningsExact identifier
unii: 15FIX9V2JP
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Premier Plastic Surgery4d39b64c-2e27-afed-e063-6394a90a38122026-03-17WarningsExact identifier
unii: 15FIX9V2JP
PowderTITANIUM DIOXIDEOxygen Development LLC4d39ed7a-ca80-893c-e063-6294a90a03e72026-03-17WarningsExact identifier
unii: 15FIX9V2JP
PowderTITANIUM DIOXIDEOxygen Development LLC4d3a0a92-b0de-a1ea-e063-6294a90a85082026-03-17WarningsExact identifier
unii: 15FIX9V2JP
Coral Isle SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDerma Care Research Labs, LLC0aafab44-0481-2a22-e063-6294a90abef22026-03-17WarningsExact identifier
unii: 15FIX9V2JP
SUMMER FRIDAYS SHADEDROPS BROAD SPECTRUM MINERAL MILK SUNSCREEN SPF 50TITANIUM DIOXIDE, ZINC OXIDESummer Friday's LLC4d3e982f-3489-dce2-e063-6294a90a1b9d2026-03-17WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Cream410 NMelaleuca Inc.2f380433-3369-9d05-e063-6394a90a64792026-03-17WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Cream115 NMelaleuca Inc.2f132cc0-e8e3-35e3-e063-6394a90a4f3d2026-03-17WarningsExact identifier
unii: 15FIX9V2JP
Tinted Sunscreen Broad SPF30TINTED SUNSCREEN BROAD SPF30DOSCHER FAMILY HEALTH NP P.C.4d4021ba-4b29-6b81-e063-6294a90a5ea72026-03-17WarningsExact identifier
unii: 15FIX9V2JP
OlanzapineOLANZAPINEHEC Pharm USA Inc.4d1b83db-54db-d51f-e063-6394a90a4a692026-03-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OLANZAPINEOLANZAPINEHEC Pharm USA Inc.4d34f8f3-edc8-0a68-e063-6394a90a9c1f2026-03-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA206238
ndc (package): 72303-0837-1
ndc (package): 72303-0840-1
ndc (package): 72303-0838-1
ndc (package): 72303-0839-1
ndc (package): 72303-0835-1
ndc (package): 72303-0836-1
ndc (product): 72303-0835
ndc (product): 72303-0836
ndc (product): 72303-0837
ndc (product): 72303-0838
ndc (product): 72303-0840
ndc (product): 72303-0839
ndc11 (package): 72303083501
rxcui: 200034
rxcui: 283639
rxcui: 312079
rxcui: 312077
rxcui: 314154
rxcui: 312078
spl id: 4d2e9776-65f4-cb00-e063-6394a90a1bf7
spl set id: 4d34f8f3-edc8-0a68-e063-6394a90a9c1f
unii: N7U69T4SZR

Reported adverse events (FAERS/openFDA)#

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