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 7 of 36 · 710 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TUMS SmoothiesCALCIUM CARBONATEHaleon US Holdings LLCc22944b8-8733-4689-be0c-f320467f79ea2026-04-01WarningsExact identifier
unii: H0G9379FGK
Soothe childrensCALCIUM CARBONATEWalgreen Company0235e083-5f3d-4bae-b14a-b12db623180c2026-03-31WarningsExact identifier
unii: H0G9379FGK
AMAZON ULTRA STRENGTH ANTACIDCALCIUM CARBONATEAMAZON.COM SERVICES LLC36cf072c-ab61-47de-8fbc-f1d1d981ec842026-03-27WarningsExact identifier
unii: H0G9379FGK
Ultra Strength Assorted Fruit AntacidCALCIUM CARBONATEHyvee Inc44eaa023-0f11-1256-e063-6394a90a41672026-03-26WarningsExact identifier
unii: H0G9379FGK
Ultra Strength AntacidCALCIUM CARBONATEGrocery Outlet, Inc.4465441f-c518-8c1d-e063-6294a90a74072026-03-25WarningsExact identifier
unii: H0G9379FGK
Ultra Strength Assorted Berry AntacidCALCIUM CARBONATEHyvee Inc44ea74ce-2b9f-e578-e063-6394a90ab72d2026-03-25WarningsExact identifier
unii: H0G9379FGK
Antacid MeltsCALCIUM CARBONATE 250MGQuest Products, LLC4dcc5323-eafe-0dc8-e063-6294a90acb602026-03-24WarningsExact identifier
unii: H0G9379FGK
GOOD SENSE DUAL ACTION COMPLETEFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEL. Perrigo Companyb5a36da3-7316-493c-b50f-fc5393d858c02026-03-24WarningsExact identifier
unii: H0G9379FGK
Extra Strength Assorted Berry AntacidCALCIUM CARBONATEHyvee Inc44eb8cf6-d8f0-0e08-e063-6394a90ac8ef2026-03-20WarningsExact identifier
unii: H0G9379FGK
ACID REDUCER COMPLETEFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEWalgreen Companyb94b16d3-b52f-4d70-bbb0-d9fb074c891c2026-03-19WarningsExact identifier
unii: H0G9379FGK
Extra Strength AntacidCALCIUM CARBONATEGrocery Outlet, Inc.44657e4a-6093-bcab-e063-6394a90a48372026-03-19WarningsExact identifier
unii: H0G9379FGK
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDEKenvue Brands LLCe874118f-b4fe-4c80-aece-99ea20e7e8052026-03-12WarningsExact identifier
unii: H0G9379FGK
Alka-Seltzer Heartburn Plus Gas ReliefChews Tropical PunchCALCIUM CARBONATE AND SIMETHICONEBayer HealthCare LLC.41d17406-3653-4889-81df-6270b7b5d3c72026-03-12WarningsExact identifier
unii: H0G9379FGK
AMAZON Ultra Strength Tropical FruitANTACID TABLETS (CALCIUM CARBONATE)AMAZON.COM SERVICES LLCdd93a70e-8b43-495e-bda3-526e5d6de9532026-03-12WarningsExact identifier
unii: H0G9379FGK
complete dual actionFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEHyVee Inc237efe92-b302-4e11-93fe-7b0f727a00aa2026-03-12WarningsExact identifier
unii: H0G9379FGK
Acid Reducer CompleteFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEWalgreen Company6f1dcfda-c12a-4c3b-80a2-c9e15517c88f2026-03-03WarningsExact identifier
unii: H0G9379FGK
SEYIPCALCIUM CARBONATESeaip co., Ltdd98d8626-8c42-77a5-e053-2a95a90a78e22026-03-03WarningsExact identifier
unii: H0G9379FGK
Nova AntacidCALCIUM CARBONATEBlueberri Inc.48696198-fc2b-eb24-e063-6294a90a3eae2026-03-02WarningsExact identifier
unii: H0G9379FGK
REGULAR STRENGTH ANTACID PEPPERMINTCALCIUM CARBONATEAKRON PHARMA INC3fb78d78-5296-4197-e063-6294a90adaae2026-03-02WarningsExact identifier
unii: H0G9379FGK
911 Adrenal Burnout and FatigueACETICUM AC, ADRENALINUM, ADRENOCORTICOTROPHIN (30X), AESCULUS HIPPOCASTANUM, FLOS, ALFALFA, ALPHA-LIPOIC AC, AMBRA, ARG NIT, AVENA SATIVA, BRYONIA, CARBONEUM OXYGENISATUM, CARPINUS BETULUS, FLOS, DNA, FUMARICUM ACIDUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, HYPOTHALAMUS, KALI PHOSPHORICUM, LACTICUM ACIDUM, LECITHIN, NATRUM MURIATICUM, OXALICUM ACIDUM, PHOSPHORICUM ACIDUM, PITUITARUM POSTERIUM, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SEPIA, SILICEA, SUCCINICUM ACIDUM AND THYROIDINUM.King Bio Inc.21c6b6c1-e846-4f25-a1dc-02e79d1be7562026-02-26WarningsExact identifier
unii: 88XHZ13131

Reported adverse events (FAERS/openFDA)#

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