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 75 of 176 · 3,517 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-Seltzer Kids Tummy ReliefChewsCALCIUM CARBONATE AND DIMETHICONEBayer HealthCare LLC.ba48966e-3762-5fdf-e053-2995a90aeb3d2025-12-04WarningsExact identifier
unii: H0G9379FGK
Alka-Seltzer Extra Strength Heartburn ReliefChewsCALCIUM CARBONATEBayer HealthCare LLC.51759451-63a8-0fb4-e054-00144ff8d46c2025-12-04WarningsExact identifier
unii: H0G9379FGK
Alka-Seltzer HeartburnANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer HealthCare LLC.55158e50-0327-2043-e054-00144ff8d46c2025-12-04WarningsExact identifier
unii: 8MDF5V39QO
Alka-Seltzer Cool Action Extra Strength ReliefChews MintCALCIUM CARBONATEBayer HealthCare LLC.849bd52a-b730-3ba7-e053-2a91aa0a507c2025-12-04WarningsExact identifier
unii: H0G9379FGK
Alka-Seltzer Ultra Strength Heartburn ReliefChews Strawberry and OrangeCALCIUM CARBONATEBayer HealthCare LLC.84771ac5-ad0b-e0ec-e053-2a91aa0a1b362025-12-04WarningsExact identifier
unii: H0G9379FGK
Alka-Seltzer Heartburn ReliefChews Strawberry and OrangeCALCIUM CARBONATEBayer HealthCare LLC.8745ae49-e6d6-43d6-9530-bcdf0b6c90e52025-12-04WarningsExact identifier
unii: H0G9379FGK
Alka-Seltzer Heartburn ReliefChewsCALCIUM CARBONATEBayer HealthCare LLC.bdb43d3b-ddcd-4359-a174-a5556e7c5f572025-12-04WarningsExact identifier
unii: H0G9379FGK
Alka-Seltzer Ultra Strength Heartburn ReliefChewsCALCIUM CARBONATEBayer HealthCare LLC.7857c357-38cb-2f61-e053-2991aa0a66022025-12-04WarningsExact identifier
unii: H0G9379FGK
Alka-Seltzer Extra StrengthANHYDROUS CITRIC ACID, SODIUM BICARBONATE, AND ASPIRINBayer HealthCare LLC.49b73bd5-6465-05eb-e054-00144ff88e882025-12-04WarningsExact identifier
unii: 8MDF5V39QO
Alka-Seltzer GoldALKA-SELTZER GOLDBayer HealthCare LLC.0824bedb-413b-2fa0-e054-00144ff88e882025-12-04WarningsExact identifier
unii: 8MDF5V39QO
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATEBayer HealthCare LLC.5be36a7f-7d1f-468d-9c29-92c8cd3ef1bc2025-12-04WarningsExact identifier
unii: 8MDF5V39QO
OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE AND SODIUM BICARBONATEAurohealth LLC88ad2e92-2228-49b2-bcee-1770fd30cb142025-12-04WarningsExact identifier
unii: 8MDF5V39QO
CVS Tropical FruitANTACIDCVS321fce7a-90be-45f2-b3a5-6b92d4f6ddb32025-12-04WarningsExact identifier
unii: H0G9379FGK
Quality Choice Chewable Antacid Assorted FruitANTACID TABLETSChain Drug Marketing Associationc1171d19-5694-4e6c-9865-40c5f62c4f052025-12-03WarningsExact identifier
unii: H0G9379FGK
Quality Choice Antacid Assorted FruitCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATIONbfb80841-edda-482b-b401-e5f1cd52440e2025-12-03WarningsExact identifier
unii: H0G9379FGK
Quality Choice Regular Strength Peppermint FlavorCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATIONea1abf51-7d10-4b1f-8eca-c5f94892bfe72025-12-03WarningsExact identifier
unii: H0G9379FGK
QC Regular StrengthANTACIDQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)1dd6df9a-241b-4a85-b31a-0741e916ae462025-12-03WarningsExact identifier
unii: H0G9379FGK
Quality Choice Assorted Berries Extra StrengthCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATIONc7f26b0a-f2c4-4ed2-9673-52f90d1a41c92025-12-03WarningsExact identifier
unii: H0G9379FGK
Quality Choice Extra Strength Assorted FruitCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATION639b39b5-44e0-4bba-8887-ce62cfac68372025-12-03WarningsExact identifier
unii: H0G9379FGK
QC Antacid Calcium Assorted BerryCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATION INC.82f5e540-a1b2-48e2-9b1d-ff52c29f78352025-12-03WarningsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

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