FDA.reportPublic FDA data

NDC 89141-448-01 - ZUPLENZ

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
89141-448
Requested NDC
89141-448-01
Package NDCs from labels
89141-448-01, 89141-448-30
Manufacturer
Fortovia Therapeutics, Inc. | Aquestive Therapeutics
Effective date
2021-10-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ZUPLENZ - Fortovia Therapeutics, Inc. | Aquestive TherapeuticsFortovia Therapeutics, Inc. | Aquestive Therapeutics2021-10-20HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
89141-448-302021-10-20C16284748780-1c7ccaba7-1b6f-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use ZUPLENZ ® safely and effectively. See full prescribing information for ZUPLENZ. ZUPLENZ (ondansetron) Oral Soluble Film Initial U.S. Approval: 1991
89141-448-302021-07-23C16284748780-1c7ccaba7-1b6f-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use ZUPLENZ ® safely and effectively. See full prescribing information for ZUPLENZ. ZUPLENZ (ondansetron) Oral Soluble Film Initial U.S. Approval: 1991

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
89141-448-01EA - Each89141-44809ade7b6-cf8e-4924-8025-0249f10b166c12017-03-06
89141-448-30EA - Each89141-448660d5a2e-8c15-4464-bbd0-bcf024ebf39212017-03-06

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 110 of 175 · 3,494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sinus Wash Saline Refills MeijerSODIUM BICARBONATE, SODIUM CHLORIDEMeijer, Inc.dd7465fe-503a-4e34-e053-2995a90a27782025-01-31WarningsExact identifier
unii: 8MDF5V39QO
SinuCleanseSODIUM BICARBONATE, SODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC.ff4df6c5-c85f-406a-89d7-8c2853fd5e102025-01-31WarningsExact identifier
unii: 8MDF5V39QO
CVSSODIUM BICARBONATE, SODIUM CHLORIDECVS Pharmacybccefef8-f92d-42fc-90fc-86644d1df6552025-01-31WarningsExact identifier
unii: 8MDF5V39QO
SunStation USA SPF-30 SPORT SUNSCREENZINC OXIDERENU LABORATORIES, LLC11d3c60e-238d-999e-e063-6394a90a624b2025-01-31WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE AND ZINC OXIDEDERM ASSO. MID OHIO2d04bc5d-6f11-4f56-e063-6294a90ae7552025-01-31WarningsExact identifier
unii: 15FIX9V2JP
Well at WalgreensSODIUM BICARBONATE, SODIUM CHLORIDEWalgreen Companybcd336b4-9189-44d5-ae6d-81e535eff6b52025-01-31WarningsExact identifier
unii: 8MDF5V39QO
SinuCleanseSODIUM BICARBONATE, SODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC.c33bf872-54aa-45e0-9e40-a6565a13f1982025-01-31WarningsExact identifier
unii: 8MDF5V39QO
TiZO Mineral Sun Defense SPF 50TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.2d0766a1-4091-e84a-e063-6394a90a004a2025-01-31WarningsExact identifier
unii: 15FIX9V2JP
Sodium Bicarbonate 10 gr (650 mg)SODIUM BICARBONATECitraGen Pharmaceuticals Inc.650fa284-5829-588f-e053-2991aa0a9a0e2025-01-30WarningsExact identifier
unii: 8MDF5V39QO
Sodium Bicarbonate 5 gr (325 mg)SODIUM BICARBONATECitraGen Pharmaceuticals Inc.68aadbd9-f1c6-8a23-e053-2991aa0afd962025-01-30WarningsExact identifier
unii: 8MDF5V39QO
Calcium Carbonate 1250 mgCALCIUM CARBONATECitraGen Pharmaceuticals, Inc.766b3f3f-8bd1-281c-e053-2991aa0af54b2025-01-30WarningsExact identifier
unii: H0G9379FGK
Calcium Carbonate 10 gr (648 mg)CALCIUM CARBONATECitraGen Pharmaceuticals, Inc.723b940d-4f4b-f2e6-e053-2991aa0a8bcc2025-01-30WarningsExact identifier
unii: H0G9379FGK
COVER plus CORRECT/TINTED MOISTURIZER CC CRM FAIROCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDEBluemercury5c590aed-d2f2-4478-8919-37c848752b422025-01-29WarningsExact identifier
unii: 15FIX9V2JP
LiProtect SPF 35ZINC OXIDE, TITANIUM DIOXIDEScience of Skincare0d0a2657-4098-3c60-e063-6294a90acabb2025-01-29WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEBELLE MEDICAL LLC2cdc69d3-2192-7a38-e063-6294a90a257f2025-01-29WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEBoxbar Beauty LLC2d04c5e7-f3aa-873f-e063-6294a90a33d22025-01-29WarningsExact identifier
unii: 15FIX9V2JP
ConstipationECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUMNewton Laboratories, Inc.9d63b107-cd47-d9a5-e053-2a95a90a44932025-01-28WarningsExact identifier
unii: ETJ7Z6XBU4
TiZO Mineral Sun Defense SPF 50TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.2cc8f7ef-eda3-fe71-e063-6394a90a6a9a2025-01-28WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEZ&Z Skin Essentials2cdc48f3-474f-9c06-e063-6294a90afea12025-01-27WarningsExact identifier
unii: 15FIX9V2JP
Ultra Strength AntacidCALCIUM CARBONATECVS2bc4c71c-a9c5-17df-e063-6294a90ac88c2025-01-27WarningsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

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