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 99 of 176 · 3,517 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OndansetronONDANSETRONAurobindo Pharma Limitedcab63f24-8728-4927-aba5-53e8d2e44cdb2025-07-08Warnings, Adverse reactionsExact identifier
unii: 4AF302ESOS
Dual Action CompleteFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEKroger Companybf2fcb88-418f-4d5d-85ba-ec165a53ab042025-07-07WarningsExact identifier
unii: H0G9379FGK
Schuessler Tissue Salts Silica 6X Cleanser and Conditioner 12SILICEAMartin & Pleasance Pty Ltd39620db9-5099-47f0-93ad-c00e6625c4622025-07-07WarningsExact identifier
unii: ETJ7Z6XBU4
MGC Health Antacid Soft Chews Cherry FlavorCALCIUM CARBONATEXiamen Kang Zhongyuan Biotechnology Co., Ltd.3958ec0a-8f32-6918-e063-6294a90ac1c42025-07-07WarningsExact identifier
unii: H0G9379FGK
Equate Acid Reducer CompleteFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEWal-Mart Stores Inccb683c1c-db81-40a9-9ec5-f8dfa0dcf8122025-07-07WarningsExact identifier
unii: H0G9379FGK
Dual Action CompleteFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEH E Bea712fc4-7f27-4556-b1b8-028f3f6ce57a2025-07-07WarningsExact identifier
unii: H0G9379FGK
DG Health acid reducer completeFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEDolgencorp, LLC95c2c515-0f31-49d9-b799-7aaded81a37c2025-07-07WarningsExact identifier
unii: H0G9379FGK
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDECAPE COD SKIN CARE CO. INC.39093b2d-3fbb-8378-e063-6294a90ac6d82025-07-03Exact identifier
unii: 15FIX9V2JP
topcare dual action completeFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDETopco Associates LLC8ef70327-9a04-413b-b331-f5d3a94d6b362025-07-01WarningsExact identifier
unii: H0G9379FGK
KOSHER MEDS antacidCALCIUM CARBONATEMollec Inc7783d6a2-56e3-4542-ad1d-60680e03532b2025-07-01WarningsExact identifier
unii: H0G9379FGK
Acid Reducer CompleteFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEWalgreen Company3a456dab-0a2d-4e48-a8e2-e49a7acef9632025-07-01WarningsExact identifier
unii: H0G9379FGK
Dual Action CompleteFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEH E Bc1aa7efa-4be1-4c8f-8994-661dd60e1aa92025-07-01WarningsExact identifier
unii: H0G9379FGK
leader acid reducer completeFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDECardinal Health 110, LLC. dba Leadera5420ef1-313f-4561-baf1-7ae017ea343a2025-07-01WarningsExact identifier
unii: H0G9379FGK
Arnica Calendula WoundARNICA CALENDULA WOUNDUriel Pharmacy, Inc38cfd292-4dbd-2caf-e063-6394a90a05272025-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
BacAPIS MELLIFERA, ARSENIC TRIOXIDE, ATROPA BELLADONNA, MATRICARIA CHAMOMILLA FLOWERING TOP OIL, LACHESIS MUTA VENOM, MERCURIUS SOLUBILIS, PULSATILLA VULGARIS WHOLE, TOXICODENDRON PUBESCENS LEAF, AND SILICON DIOXIDEZorex7ae38e0c-8e74-4fd5-8605-45e424a84d012025-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
Vertra S Dorian Kona Gold Signature Face Stick SPF 38TITANIUM DIOXIDEToshiki Pigment Co., ltd.b7162a2f-07f1-6188-e053-2995a90a8a9c2025-06-27WarningsExact identifier
unii: 15FIX9V2JP
Bambusa AurumBAMBUSA AURUMUriel Pharmacy Inc.43f3dd30-701f-4fa4-9743-d10051c6e6d42025-06-27WarningsExact identifier
unii: ETJ7Z6XBU4
SODIUM BICARBONATESODIUM BICARBONATEAnthea Pharma Private Limited0df8cf62-4b49-4ec4-aae4-c4a3e6d765492025-06-26Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
MELAO WHITENING SUNSCREENTITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd1aaf5942-ff13-ee07-e063-6394a90acd282025-06-25WarningsExact identifier
unii: 15FIX9V2JP
OndansetronONDANSETRONNuCare Pharmaceuticals,Inc.72f29916-0f95-102d-e053-2991aa0aa5cd2025-06-24Warnings, Adverse reactionsExact identifier
unii: 4AF302ESOS

Reported adverse events (FAERS/openFDA)#

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