FDA.reportPublic FDA data

NDC 72384-752-01 - 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
72384-752
Requested NDC
72384-752-01
Package NDCs from labels
72384-752-30, 72384-752-01, 72384-752-99
Manufacturer
Metuchen Pharmaceuticals, LLC
Effective date
2024-07-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Stendra - Metuchen Pharmaceuticals, LLCMetuchen Pharmaceuticals, LLC2024-07-18HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
72384-752-302026-01-29These 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
72384-752-992026-01-29These 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
72384-752-302024-01-30These 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
72384-752-992024-01-30These 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72384-752-01Stendra1 in 1 BLISTER PACKTABLET17
72384-752-30Stendra30 in 1 BOTTLETABLET307
72384-752-99Stendra6 in 1 CARTONTABLET67

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72384-752STENDRA (AVANAFIL) TABLET [METUCHEN PHARMACEUTICALS, LLC]7Legacy NDC, 3 package rows20240724_fa7d93e3-b69b-4e02-8146-89760cd8e9d6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72384-752-30EA - Each72384-752c370e575-434d-4332-8d7e-38ed73977cf012022-05-04

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
f44369fe-9831-437f-aa49-d1e833973371fa7d93e3-b69b-4e02-8146-89760cd8e9d62024-07-18Warnings, Adverse reactionsExact identifier
spl id: f44369fe-9831-437f-aa49-d1e833973371
spl set id: fa7d93e3-b69b-4e02-8146-89760cd8e9d6
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

Reported adverse events (FAERS/openFDA)#

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