FDA.reportPublic FDA data

NDC 76299-321-01 - Stendra

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
76299-321
Requested NDC
76299-321-01
Package NDCs from labels
76299-321-01, 76299-321-96, 76299-321-85, 76299-321-88
Manufacturer
Mist Pharmaceuticals, LLC
Effective date
2021-05-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Stendra - Mist Pharmaceuticals, LLCMist Pharmaceuticals, LLC2021-05-24HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
76299-321-852023-02-15These highlights do not include all the information needed to use STENDRA safely and effectively. See full prescribing information for STENDRA . STENDRA ® (avanafil) tablets, for oral use Initial U.S. Approval: 2012
76299-321-882023-02-15These highlights do not include all the information needed to use STENDRA safely and effectively. See full prescribing information for STENDRA . STENDRA ® (avanafil) tablets, for oral use Initial U.S. Approval: 2012
76299-321-962023-02-15These highlights do not include all the information needed to use STENDRA safely and effectively. See full prescribing information for STENDRA . STENDRA ® (avanafil) tablets, for oral use Initial U.S. Approval: 2012
76299-321-852023-01-30These highlights do not include all the information needed to use STENDRA safely and effectively. See full prescribing information for STENDRA . STENDRA ® (avanafil) tablets, for oral use Initial U.S. Approval: 2012
76299-321-882023-01-30These highlights do not include all the information needed to use STENDRA safely and effectively. See full prescribing information for STENDRA . STENDRA ® (avanafil) tablets, for oral use Initial U.S. Approval: 2012
76299-321-962023-01-30These highlights do not include all the information needed to use STENDRA safely and effectively. See full prescribing information for STENDRA . STENDRA ® (avanafil) tablets, for oral use Initial U.S. Approval: 2012
76299-321-852020-07-02These highlights do not include all the information needed to use STENDRA safely and effectively. See full prescribing information for STENDRA . STENDRA ® (avanafil) tablets, for oral use Initial U.S. Approval: 2012
76299-321-882020-07-02These highlights do not include all the information needed to use STENDRA safely and effectively. See full prescribing information for STENDRA . STENDRA ® (avanafil) tablets, for oral use Initial U.S. Approval: 2012
76299-321-962020-07-02These highlights do not include all the information needed to use STENDRA safely and effectively. See full prescribing information for STENDRA . STENDRA ® (avanafil) tablets, for oral use Initial U.S. Approval: 2012
76299-321-852020-01-31These highlights do not include all the information needed to use STENDRA safely and effectively. See full prescribing information for STENDRA . STENDRA ® (avanafil) tablets, for oral use Initial U.S. Approval: 2012
76299-321-882020-01-31These highlights do not include all the information needed to use STENDRA safely and effectively. See full prescribing information for STENDRA . STENDRA ® (avanafil) tablets, for oral use Initial U.S. Approval: 2012
76299-321-962020-01-31These highlights do not include all the information needed to use STENDRA safely and effectively. See full prescribing information for STENDRA . STENDRA ® (avanafil) tablets, for oral use Initial U.S. Approval: 2012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76299-321-85EA - Each76299-321afabd2ea-ffbc-4328-acef-1ea2a234c3ce12017-08-11

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 30 of 36 · 710 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GDC Extra strength Alkums Antacid 127AFCALCIUM CARBONATEGuardian Drug Company1b6da4a3-cfa6-6d98-e063-6394a90a58892024-08-13WarningsExact identifier
unii: H0G9379FGK
Wonderbelly Maximum Strength Antacid - Sweet MintCALCIUM CARBONATEGinger Health Company17ddf76b-237a-eeee-e063-6294a90ac2052024-07-29WarningsExact identifier
unii: H0G9379FGK
Calcium Carbonate Assorted FlavorsANTACID TABLETSNuCare Pharmaceuticals,Inc.af10dfb6-fef3-3410-e053-2995a90a91302024-07-17WarningsExact identifier
unii: H0G9379FGK
Good Neighbor Pharmacy Antacid Regular StrengthCALCIUM CARBONATEAmerisourceBergen Drug Corporation2847e82e-203e-4976-8c4f-4a5caa75ce002024-07-09WarningsExact identifier
unii: H0G9379FGK
Kirkland Ultra Stregth Antacid 171ABCALCIUM CARBONATECOSTCO WHOLESALE COMPANY1bea92e8-1b94-77b0-e063-6394a90a82122024-07-08WarningsExact identifier
unii: H0G9379FGK
Regular Strength AntacidCALCIUM CARBONATEAmerisource Bergenf9dd2797-c804-43c4-9d64-47de3b63a19a2024-06-28WarningsExact identifier
unii: H0G9379FGK
Ultra Strength Antacid Assorted FruitCALCIUM CARBONATEAmerisource Bergend39b3a19-b0e7-409d-9e0b-ef847fe8be2f2024-06-26WarningsExact identifier
unii: H0G9379FGK
Extra Strength sugar free AntacidCALCIUM CARBONATEAmerisource Bergen541a8e91-9438-4ebd-8bfc-a2674f6a9c4a2024-06-17WarningsExact identifier
unii: H0G9379FGK
Mylanta All-Family Multi Symptom Stomach RemedyCALCIUM CARBONATE, SIMETHICONEInfirst Healthcare Inc.19118884-2016-e86e-e063-6294a90a370c2024-05-22WarningsExact identifier
unii: H0G9379FGK
Equaline Ultra Strength Antacid Assorted Berry Ultra strength Assorted Fruit AntacidCALCIUM CARBONATEUNITED NATURAL FOODS, INC. DBA UNFI3e18b19f-063c-4d6e-9bf2-4fdc04e640892024-05-12WarningsExact identifier
unii: H0G9379FGK
EQU Ultra Strength Antacid Assorted Fruit 171AFCALCIUM CARBONATEUNITED NATURAL FOODS, INC. DBA UNFI8cfe3fe3-99fa-44ae-a68e-8c8e97e231772024-05-12WarningsExact identifier
unii: H0G9379FGK
Prenatol-MMULTIVITAMINPureTek Corporation17559a44-94b7-9ca0-e063-6294a90a21232024-05-06Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
Tums Chewy Bites PeppermintCALCIUM CARBONATEHaleon US Holdings LLC45a44b2b-1633-49c5-8c55-9e9af3545c922024-05-03WarningsExact identifier
unii: H0G9379FGK
Equqline Extra Strength Antacid Assorted FruitCALCIUM CARBONATEUNITED NATURAL FOODS, INC. DBA UNFI270c35f6-8ce2-4e88-940b-a02a749817582024-05-01WarningsExact identifier
unii: H0G9379FGK
Equaline Extra Strength Assorted Berry AntacidCALCIUM CARBONATEUNITED NATURAL FOODS, INC. DBA UNFI61d2e663-f0cf-4c14-a4f0-09897c760b132024-05-01WarningsExact identifier
unii: H0G9379FGK
Guardian Extra Strength Smooth Alkum Antacid 173bfCALCIUM CARBONATEGuardian Drug Companyae324739-8497-47aa-9e68-cbe42dfd83012024-05-01WarningsExact identifier
unii: H0G9379FGK
EQUALINE Regular Strength Antacid PeppermintCALCIUM CARBONATEUNITED NATURAL FOODS, INC. DBA UNFIea361a6e-70b6-42b9-b64c-05d5d038cf6a2024-04-30WarningsExact identifier
unii: H0G9379FGK
Guardian Ultra Strength Antacid Assorted FruitCALCIUM CARBONATEGuardian Drug Company0579de6c-8c25-4b7c-9184-1f73537fc2312024-04-29WarningsExact identifier
unii: H0G9379FGK
GlucoregASCORBICUM ACIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SARCOLACTICUM ACIDUM, THIAMINUM HYDROCHLORICUM, DHEA (DEHYDROEPIANDROSTERONE), ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-LIPOICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, NADIDUM, PANTOTHENIC ACID, ACETALDEHYDE, INSULINUM (SUIS), INSULINUM (HUMAN), HEPAR SUIS, PANCREAS SUIS, PHLORIDZINUM, ALLOXANUM, BERBERIS VULGARIS, CARCINOSIN, LYCOPODIUM CLAVATUM, MOMORDICA BALSAMINA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SYZYGIUM JAMBOLANUM,Deseret Biologicals, Inc.c77d0682-a000-4783-a91c-d4e205c347742024-04-29WarningsExact identifier
unii: 88XHZ13131
Equqline Regular Strength AntacidCALCIUM CARBONATEUNITED NATURAL FOODS, INC. DBA UNFIaae36cef-404b-4bb0-b107-58140c4ab8912024-04-28WarningsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

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