FDA.reportPublic FDA data

NDC 68071-4328-01 - Ondansetron Hydrochloride

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
68071-4328
Requested NDC
68071-4328-01
Package NDCs from labels
68071-4328-1, 68071-4328-4, 68071-4328-01
Manufacturer
NuCare Pharmceuticals,Inc. | NuCare Pharmaceuticals,Inc.
Effective date
2024-06-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ANHYDROUS LACTOSE - NuCare Pharmceuticals,Inc. | NuCare Pharmaceuticals,Inc.NuCare Pharmceuticals,Inc. | NuCare Pharmaceuticals,Inc.2024-06-07HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68071-4328-12021-02-16These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
68071-4328-42021-02-16These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
68071-4328-12021-01-29These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
68071-4328-42021-01-29These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4328-1Ondansetron Hydrochloride10 in 1 BOTTLETABLET, FILM COATED107
68071-4328-4Ondansetron Hydrochloride4 in 1 BOTTLETABLET, FILM COATED47

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4328ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMCEUTICALS,INC.]7Current NDC, Legacy NDC, 2 package rows20240608_67395789-0ac7-2244-e053-2a91aa0a652a.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 3 of 107 · 2,125 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
unii: 15FIX9V2JP
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
unii: 15FIX9V2JP
ONDANSETRONONDANSETRONSportpharm LLCde72f1ec-75dd-4659-a1a0-32b28b72c7992026-07-02Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
unii: 15FIX9V2JP
Evereden Fluid Silk Mineral Sunscreen PRO SPF50TITANIUM DIOXIDE, ZINC OXIDEEden Brands Inc.2cb7773f-9a05-ad02-e063-6294a90af0242026-07-01WarningsExact identifier
unii: 15FIX9V2JP
OHUI Ultimate Cover CC Cushion Compact 01 Light BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d2f9c54b-ac4e-5141-e053-2a95a90aa2b82026-06-30WarningsExact identifier
unii: 15FIX9V2JP
TOCOBO Blur Finish Sun Cushion Cotton BlueHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEPICTON Co., Ltd.4d6ddee3-9a76-6c9c-e063-6394a90a15292026-06-29WarningsExact identifier
unii: 15FIX9V2JP
Earth Baby Broad Spectrum SPF 30SUNSCREENEarth Baby, Inc.42556876-74ea-38e6-e054-00144ff8d46c2026-06-28WarningsExact identifier
unii: 15FIX9V2JP
Sun Does Matter Daily Face SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDESundoesmatter Company Inc.553687d8-d4e1-8361-e063-6294a90a24fe2026-06-27WarningsExact identifier
unii: 15FIX9V2JP
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDESt. Mary's Medical Park Pharmacy58f16a00-3e66-29de-e053-2991aa0a59a02026-06-26Warnings, Adverse reactionsExact identifier
application number: ANDA078539
rxcui: 198052
unii: NMH84OZK2B
Ivory Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f25ba-61d5-6a94-e063-6394a90a46e92026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Simply Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f4799-9122-8db5-e063-6394a90a51322026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Vanilla Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f6d2c-9b8c-aa52-e063-6294a90a787e2026-06-26WarningsExact identifier
unii: 15FIX9V2JP
OndansetronONDANSETRONCardinal Health 107, LLC1b9c2d9f-62a8-4d26-a041-a598bc59e3002026-06-26Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
Coral Isle SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERocky Mountain5515f562-62d9-c6ee-e063-6294a90a9ea62026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEAmerican Health Packaging9f015e60-1aec-4ae7-b28f-42f6c8f504552026-06-25Warnings, Adverse reactionsExact identifier
application number: ANDA078539
rxcui: 312086
rxcui: 198052
unii: NMH84OZK2B
Delicate Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551928b4-74bb-3f6c-e063-6294a90a6b832026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc5519290c-b040-6a37-e063-6394a90a8a1d2026-06-25WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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