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 32 of 36 · 710 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tums Chewy BitesCALCIUM CARBONATEHaleon US Holdings LLC5090f60f-fa98-470b-bafd-bb64e6b28fcc2024-03-02WarningsExact identifier
unii: H0G9379FGK
Tums Chewy BitesCALCIUM CARBONATEHaleon US Holdings LLC453ceee1-414b-4f4c-8408-eb540a79ca052024-03-02WarningsExact identifier
unii: H0G9379FGK
Tums Chewy Bites Berry ShakeCALCIUM CARBONATEHaleon US Holdings LLC9043983c-7ee4-4971-8885-36f814bb570f2024-03-02WarningsExact identifier
unii: H0G9379FGK
Tums Chewy DelightsCALCIUM CARBONATEHaleon US Holdings LLC189850d0-6f06-45bd-bd7e-9063ee580d0b2024-03-02WarningsExact identifier
unii: H0G9379FGK
Family Wellness Ultra Strength Assorted Fruit Antacid Ultra strength Assorted Fruit AntacidCALCIUM CARBONATEFamily Dollar Services, Inc.11a0bbf8-bfc9-4595-8792-f148a9029b192024-02-23WarningsExact identifier
unii: H0G9379FGK
Foster and Thrive Extra Strength Sugar Free Antacid OrangeCALCIUM CARBONATEStrategic Sourcing Services LLCa5936b84-b1ad-4622-82de-ca7f43093c192024-02-21WarningsExact identifier
unii: H0G9379FGK
EnergizeSARCOLACTICUM ACIDUM, VISCUM ALBUM, IODIUM, FUCUS VESICULOSUS, GALIUM APARINE, NATRUM OXALACETICUM, THYROIDINUM (SUIS), DHEA (DEHYDROEPIANDROSTERONE), PHENYL ISOTHIOCYANATE, TRI-IODOTHYRONINE, TYRAMINE, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, FUMARICUM ACIDUM, MALIC ACID, COLCHICUM AUTUMNALE, CONIUM MACULATUM, FUNICULUS UMBILICALIS SUIS, HEPAR SUIS, MEDULLA OSSIS SUIS, PINEAL GLAND (SUIS), SPLEEN (SUIS), THYMUS (SUIS), CALCAREA FLUORICA, PULSATILLA (VULGARIS), SPONGIA TOSTADeseret Biologicals, Inc.633f7d82-6cfd-4bc2-8fd3-a52bde0f9cd52024-02-19WarningsExact identifier
unii: 88XHZ13131
Family Wellness Extra Strength Antacid Extra Strength Assorted Fruit AntacidCALCIUM CARBONATEFamily Dollar Services, Inc.96a711b5-3603-4a0c-80ae-be9ccfe35d162024-02-19WarningsExact identifier
unii: H0G9379FGK
Diathesis V 2GINKGO BILOBA, PANCREAS SUIS, SPLEEN (SUIS), STOMACH (SUIS), GERMANIUM SESQUIOXIDE, COBALTUM METALLICUM, CYSTEINUM, NICCOLUM METALLICUM, ZINCUM METALLICUM, MANGANESE GLUCONATE, ALPHA-KETOGLUTARICUM ACIDUM, BARYTA CARBONICA, FUMARICUM ACIDUM, NATRUM OXALACETICUM, PHOSPHORICUM ACIDUM, PHOSPHORUSBioActive Nutritional, Inc.1f389621-b22b-4d6c-9c28-93292eb4eebf2024-02-13WarningsExact identifier
unii: 88XHZ13131
Mylanta ClassicCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEInfirst Healthcare Inc.10a4cf29-39ed-87c3-e063-6394a90a49732024-02-05WarningsExact identifier
unii: H0G9379FGK
Mylanta Vanilla CaramelCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEInfirst Healthcare Inc.10a66d74-74b4-3f8d-e063-6394a90a7f002024-02-05WarningsExact identifier
unii: H0G9379FGK
MANNITOLMANNITOLHF Acquisition Co LLC, DBA HealthFirst999ce711-2d5b-0d7d-e053-2995a90a26892024-01-27Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE CHEWABLE TABLETLil' Drug Store Products, Inc.d08984b8-ce03-9e95-e053-2995a90ae6f02024-01-25WarningsExact identifier
unii: H0G9379FGK
EnergizeSARCOLACTICUM ACIDUM, VISCUM ALBUM, IODIUM, FUCUS VESICULOSUS, GALIUM APARINE, THYROIDINUM (SUIS), DHEA (DEHYDROEPIANDROSTERONE), PHENYL ISOTHIOCYANATE, TYRAMINE, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, FUMARICUM ACIDUM, MALIC ACIDUM, COLCHICUM AUTUMNALE, CONIUM MACULATUM, NATRUM OXALACETICUM, FUNICULUS UMBILICALIS SUIS, HEPAR SUIS, MEDULLA OSSIS SUIS, PINEAL GLAND (SUIS), SPLEEN (SUIS), THYMUS (SUIS), CALCAREA FLUORICA, PULSATILLA (VULGARIS), SPONGIA TOSTA, CORTISONE ACETICUMDeseret Biologicalsaaf7ee10-86ae-41db-b0cc-e53d87cb92aa2024-01-17WarningsExact identifier
unii: 88XHZ13131
PNV-SelectVITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, DL, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, CALCIUM PANTOTHENATE, CALCIUM CARBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM OXIDE, ZINC OXIDE AND CUPRIC OXIDEAcella Pharmaceuticals, LLC9f4ce551-7a80-4ddb-a014-95c44b54a4202024-01-16Boxed warning, Adverse reactionsExact identifier
unii: H0G9379FGK
Childrens Mylicon All in One Tummy Relief for KidsANTACID AND ANTIGASInfirst Healthcare Inc.0952eba8-6de2-4a77-956d-339fab4374722024-01-01WarningsExact identifier
unii: H0G9379FGK
Mylanta Coat and CoolCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEINFIRST HEALTHCARE INC.b6571f7f-e1ea-4034-a46c-4de1d01beec32024-01-01WarningsExact identifier
unii: H0G9379FGK
MenatrolFOLATE, MULTIVITAMINPureTek Corporation0a100e7d-3a8d-2d8b-e063-6394a90a32032023-12-18Boxed warning, Adverse reactionsExact identifier
unii: H0G9379FGK
Calcium CarbonateCALCIUM CARBONATEHumco Holding Group, Inc.8b207b49-d3fd-4108-b611-dca27c9dc78a2023-12-15WarningsExact identifier
unii: H0G9379FGK
Mylanta One Antacid/Anti-GasCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONEInfirst Healthcare Inc.aa694e0d-7891-4870-8106-dd57f1e29fb42023-12-11WarningsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

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