FDA.reportPublic FDA data

NDC 68071-3801-01 - Ondansetron

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
68071-3801
Requested NDC
68071-3801-01
Package NDCs from labels
68071-3801-1, 68071-3801-01
Manufacturer
NuCare Pharmaceuticals, Inc.
Effective date
2025-02-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ondansetron - NuCare Pharmaceuticals, Inc.NuCare Pharmaceuticals, Inc.2025-02-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3801-1Ondansetron10 in 1 BOTTLETABLET, FILM COATED101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3801ONDANSETRON TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20250226_2eeb3c61-4ce9-d8ed-e063-6294a90a00d3.zip

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 58 of 107 · 2,121 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dolce and Gabbana Everlast Foundation SPF 20 40C DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lcf4b6f45-d4ae-4665-87b4-c5af4910befa2025-09-03WarningsExact identifier
unii: 15FIX9V2JP
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEPreferred Pharmaceuticals Inc.36d64400-2d13-4a1a-a1ca-4741cd3d3f1a2025-09-03Warnings, Adverse reactionsExact identifier
application number: ANDA078539
rxcui: 198052
unii: NMH84OZK2B
OndansetronONDANSETRONNorthStar Rx LLC9d5e7650-95be-4b96-b29c-374f673eb7a12025-09-03Warnings, Adverse reactionsExact identifier
application number: ANDA078539
ndc (product): 16714-160
rxcui: 312086
rxcui: 198052
spl id: 9e8d8ea3-cbef-49ef-bcda-3ae6b9ea68d1
spl set id: 9d5e7650-95be-4b96-b29c-374f673eb7a1
unii: NMH84OZK2B
Pure6 ManiShield Hand ScreenZINC OXIDE, TITANIUM DIOXIDEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3abcb6ba-1de8-55e7-e063-6294a90aecf12025-09-02WarningsExact identifier
unii: 15FIX9V2JP
toty Ilumina CC Creamy Compact 6NTITANIUM DIOXIDEChipican LLC3da732e7-19b0-3195-e063-6394a90a9a0c2025-09-01WarningsExact identifier
unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 4ENSULIZOLE ,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3dba1360-f70f-e450-e063-6394a90a8c9f2025-09-01WarningsExact identifier
unii: 15FIX9V2JP
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDERising Pharma Holdings, Inc.90e0e508-75f7-4c8b-bb38-898aa4c531c32025-09-01Warnings, Adverse reactionsExact identifier
application number: ANDA078539
rxcui: 312086
rxcui: 198052
unii: NMH84OZK2B
Dolce and Gabbana Everlast Foundation SPF 20 33N DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Le249507c-d536-4c1d-a99d-857ca1e833d82025-08-29WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 32W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lba99edea-bf68-4118-8bb7-ea40322db46a2025-08-29WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 34W DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L3a239897-9850-417f-8c00-e810a52540c12025-08-29WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 36N DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lc495afc3-6486-4652-b743-958f28eccaca2025-08-29WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 35W DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L5440ed13-b07e-4c81-a407-d9ac68eaa4832025-08-29WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 37W DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L9b2c4567-fde7-4b76-9988-b2cba2d3747e2025-08-29WarningsExact identifier
unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 2ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3d55291c-9d4c-85c3-e063-6394a90af3302025-08-27WarningsExact identifier
unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 3ENSULIZOLE ,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3d565612-ade5-bfb3-e063-6294a90a0c652025-08-27WarningsExact identifier
unii: 15FIX9V2JP
ONDANSETRONONDANSETRONProPharma Distribution3d5d25eb-8711-ef8c-e063-6394a90a5e032025-08-27Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
Sun Bum 30 Mineral Tinted Sunscreen FaceTITANIUM DIOXIDE, ZINC OXIDESun Bum, LLC3a290aad-7f40-cb10-e063-6394a90a2e692025-08-27WarningsExact identifier
unii: 15FIX9V2JP
ONDANSETRONONDANSETRONApotex Corp.2c68d202-fdf7-4b6a-dd7f-82624fcdbd4a2025-08-26Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 6ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3d0359b6-088f-aa54-e063-6394a90a422f2025-08-23WarningsExact identifier
unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 4ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3cdc1ae9-2924-5057-e063-6294a90ad2f32025-08-21WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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