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 117 of 174 · 3,480 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OndansetronONDANSETRONAdvanced Rx Pharmacy of Tennessee, LLCf1a0ea2c-0788-4e8a-e053-2a95a90a2f322024-12-31Warnings, Adverse reactionsExact identifier
unii: 4AF302ESOS
OndansetronONDANSETRONAdvanced Rx Pharmacy of Tennessee, LLCf1a0cd50-aa4f-55bc-e053-2995a90a2d3a2024-12-31Warnings, Adverse reactionsExact identifier
unii: 4AF302ESOS
OndansetronONDANSETRONNuCare Pharmaceuticals,Inc.e183c59c-2a7c-dba3-e053-2a95a90acf872024-12-30Warnings, Adverse reactionsExact identifier
unii: 4AF302ESOS
Almay Healthy Biome MakeupHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEAlmayab20969a-8640-307d-e053-2a95a90a004d2024-12-30WarningsExact identifier
unii: 15FIX9V2JP
DUAL ACTION Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE TABLET, CHEWABLELil' Drug Store Products, Inc.f3cf2e19-1348-0eac-e053-2a95a90a46c12024-12-30WarningsExact identifier
unii: H0G9379FGK
EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUSOCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLEExelencia importers Corp.2a845e4c-86e7-1799-e063-6294a90a9b2b2024-12-30WarningsExact identifier
unii: 15FIX9V2JP
SkinCeuticals Sheer Physical UV Defense Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc2035ab03-80b4-49f4-b379-eb8bc42c9cee2024-12-30WarningsExact identifier
unii: 15FIX9V2JP
SkinCeuticals Physical Matte UV Defense Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Incb137b3d0-212b-440a-b158-62ace4b4eff32024-12-30WarningsExact identifier
unii: 15FIX9V2JP
SkinCeuticals Physical UV Defense Broad Spectrum SPF 30 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc3a6db7d3-6c59-4633-a97e-1c03127246d32024-12-30WarningsExact identifier
unii: 15FIX9V2JP
OndansetronONDANSETRONAdvanced Rx of Tennessee, LLC2a8603a9-5b6f-b921-e063-6394a90ae29c2024-12-29Warnings, Adverse reactionsExact identifier
unii: 4AF302ESOS
OndansetronONDANSETRONAdvanced Rx of Tennessee, LLC2a863485-a0a8-db63-e063-6294a90ab6052024-12-29Warnings, Adverse reactionsExact identifier
unii: 4AF302ESOS
Kiehls Since 1851 Activated Sun Protector For Face and Body Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inc87496037-36ca-4c5f-973f-46626cf4096e2024-12-27WarningsExact identifier
unii: 15FIX9V2JP
RODAN and FIELDS UNBLEMISHTITANIUM DIOXIDE, ZINC OXIDEBentley Laboratories, LLC2b3b6b62-364f-4aba-8024-3a73752b4c562024-12-27WarningsExact identifier
unii: 15FIX9V2JP
NORWEX Protect Prevent Mineral Facial Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, CORPORATION0d489154-6168-977e-e063-6394a90aa6092024-12-26WarningsExact identifier
unii: 15FIX9V2JP
ANTACIDCALCIUM CARBONATEAdvance Pharmaceutical Inc.face4e8c-3d0f-4c2e-83c1-44397b225ae72024-12-26WarningsExact identifier
unii: H0G9379FGK
ANTACIDCALCIUM CARBONATEAdvance Pharmaceutical Inc.3203dfc5-2cb1-4703-8d81-63fba07ddd982024-12-26WarningsExact identifier
unii: H0G9379FGK
HEB Extra Strength Smooth Antacid Assorted FruitsCALCIUM CARBONATEH E B2faac316-7b59-4df8-b751-37069e8652632024-12-26WarningsExact identifier
unii: H0G9379FGK
Good Neighbor Pharmacy Antacid Extra StrengthCALCIUM CARBONATEAmerisourceBergen Drug Corporation5e3a3c20-dabe-4427-9e75-99759905caa02024-12-26WarningsExact identifier
unii: H0G9379FGK
HEB Extra Strength Smooth Antacid PeppermintCALCIUM CARBONATEH E Bd04e691e-6d1c-4c39-9504-7ac0f1bd197d2024-12-26WarningsExact identifier
unii: H0G9379FGK
CITY BLOCK SHEER Oil FREE DAILY FACE PROTECTOR BROAD SPECTRUM SPF 25TITANIUM DIOXIDE AND ZINC OXIDECLINIQUE LABORATORIES LLCee7e2ded-b850-4e15-96a6-556111e521872024-12-25WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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