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 107 of 175 · 3,494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength AntacidCALCIUM CARBONATEDiscount Drug Mart, Inc2df9e47a-8741-6958-e063-6394a90a6c602025-02-20WarningsExact identifier
unii: H0G9379FGK
Regular Strength Antacid PeppermintCALCIUM CARBONATEDiscount Drug Mart, Inc2e09b8d1-25b4-0e57-e063-6394a90a31e22025-02-20WarningsExact identifier
unii: H0G9379FGK
Neutrogena Healthy Skin Invisibly Radiant UV Primer SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC20cd4d96-2046-3a50-e063-6394a90a12192025-02-18WarningsExact identifier
unii: 15FIX9V2JP
HIONFURT Motion SicknessMOTION SICKNESS PREVENT NAUSEA,DIZZINESS VOMITINGPuning Huiyu E-Commerce Co., Ltd.2e31419e-3ccd-d7b5-e063-6394a90ac7652025-02-15WarningsExact identifier
unii: V95R5KMY2B
Sun Defense Minerals (Sheer)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e2082aa-5ae3-2c04-e063-6294a90a140b2025-02-14WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Light)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e21f5bb-e7df-b43b-e063-6394a90a0f822025-02-14WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Fair)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e2102c6-02ea-3a8f-e063-6394a90abf5e2025-02-14WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Medium)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e2297d4-3649-a749-e063-6294a90ac2842025-02-14WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Light)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e22cfde-10a1-3742-e063-6394a90ac0972025-02-14WarningsExact identifier
unii: 15FIX9V2JP
Tums Chewy Bites Orange and Cream ESCALCIUM CARBONATEHaleon US Holdings LLC036ef1ed-32ef-46b8-8817-b3f63a0142802025-02-14WarningsExact identifier
unii: H0G9379FGK
Neutrogena Mineral Ultra Sheer Dry Touch SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLCe99311c2-ed8b-6e60-e053-2a95a90a9bc22025-02-13WarningsExact identifier
unii: 15FIX9V2JP
Tums NaturalsCALCIUM CARBONATEHaleon US Holdings LLCd8da54b8-6456-4e7d-acd2-a55e2249bd012025-02-13WarningsExact identifier
unii: H0G9379FGK
Aurum HypericumAURUM HYPERICUMUriel Pharmacy, Inc2df4f968-af1d-82f1-e063-6294a90a65be2025-02-12WarningsExact identifier
unii: ETJ7Z6XBU4
Ultra Strength Antacid Assorted FruitCALCIUM CARBONATEHarris Teeter, LLC2cb4c58f-ee88-b60e-e063-6294a90a1e6c2025-02-12WarningsExact identifier
unii: H0G9379FGK
Regular Strength Antacid PeppermintCALCIUM CARBONATEHarris Teeter, LLC2cb54a40-98ce-2660-e063-6294a90a3ed02025-02-11WarningsExact identifier
unii: H0G9379FGK
Extra Strength Antacid Tropical FruitCALCIUM CARBONATEHarris Teeter, LLC2c65f7f5-195c-ed33-e063-6294a90a30702025-02-11WarningsExact identifier
unii: H0G9379FGK
SILICEA 6XSILICEASEVENE USAff0e0009-8bbe-e0eb-e053-6294a90afa822025-02-11WarningsExact identifier
unii: ETJ7Z6XBU4
Regular Strength AntacidCALCIUM CARBONATEHarris Teeter, LLC2cb50083-b05f-8aca-e063-6394a90a6d6f2025-02-11WarningsExact identifier
unii: H0G9379FGK
Extra Strength AntacidCALCIUM CARBONATEHarris Teeter, LLC2c544c08-8cdb-edf2-e063-6394a90a024c2025-02-11WarningsExact identifier
unii: H0G9379FGK
12 CELL SALTS COMPLEXCALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SILICEASEVENE USAff0f69cd-97a2-7183-e053-6394a90ad0392025-02-10WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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