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 23 of 36 · 710 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Se-Natal 19 ChewableVITAMINS AND MINERALSSeton Pharmaceuticalsa54dd642-8884-415a-a082-cd9fb544e4002025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
Ultra Strength Antacid Assorted FruitCALCIUM CARBONATEDeMoulas Market Basketa7257be7-bef3-4fe7-8789-cc3da45168752025-03-05WarningsExact identifier
unii: H0G9379FGK
Extra Strength Antacid Tropical FruitCALCIUM CARBONATEDeMoulas Market Basket28bb40b6-8803-413e-846f-dedc3c0532762025-03-04WarningsExact identifier
unii: H0G9379FGK
Redicare Antacid Mint FlavoredREDICARE ANTACID MINT FLAVOREDRedicare LLC2f259f79-d321-5566-e063-6294a90a15222025-03-04WarningsExact identifier
unii: H0G9379FGK
Extra Strength Assorted Berry AntacidCALCIUM CARBONATEDeMoulas Market Basket726c5e9f-55e6-416a-b001-0b56b05d7d1d2025-03-04WarningsExact identifier
unii: H0G9379FGK
Extra Strength Antacid Assorted FruitCALCIUM CARBONATEDeMoulas Market Basket9b07ad97-3f0f-401b-a855-6474b3dbdb692025-03-04WarningsExact identifier
unii: H0G9379FGK
Extra Strength Smooth Antacid Assorted FruitsCALCIUM CARBONATEGood Sense (Geiss, Destin & Dunn, Inc.)2595385c-60ad-44e5-b3e3-1b9ac53044032025-02-28WarningsExact identifier
unii: H0G9379FGK
Ultra Strength Antacid Wintergreen FlavorCALCIUM CARBONATE7-ELEVEN2f3c4e78-71d2-c46c-e063-6394a90a210a2025-02-28WarningsExact identifier
unii: H0G9379FGK
Calcium CarbonateCALCIUM CARBONATEAllegiant Health9bc5c5de-8d61-4edf-83d2-a1e797c2d24a2025-02-28WarningsExact identifier
unii: H0G9379FGK
Supreme AntacidCALCIUM CARBONATE, MAGNESIUM HYDROXIDEDiscount Drug Mart, Inc2e0b175c-2cc8-b18a-e063-6394a90a028e2025-02-27WarningsExact identifier
unii: H0G9379FGK
Extra Strength AntacidCALCIUM CARBONATEDiscount Drug Mart, Inc2e0d5be6-d41b-cdf8-e063-6394a90a08b42025-02-27WarningsExact identifier
unii: H0G9379FGK
Supreme Antacid CherryCALCIUM CARBONATE, MAGNESIUM HYDROXIDEDiscount Drug Mart, Inc2e0a1913-c3d4-7c7d-e063-6294a90a48412025-02-26WarningsExact identifier
unii: H0G9379FGK
Extra Strength sugar free AntacidCALCIUM CARBONATEDiscount Drug Mart, Inc2e09f87b-c771-59ae-e063-6294a90a0c392025-02-25WarningsExact identifier
unii: H0G9379FGK
Ultra Strength Antacid Wintergreen FlavorCALCIUM CARBONATEXiamen Kang Zhongyuan Biotechnology Co., Ltd.409b5d06-3398-4414-8919-10b9064ba4ee2025-02-25WarningsExact identifier
unii: H0G9379FGK
Extra Strength Antacid Tropical FruitCALCIUM CARBONATEDiscount Drug Mart, Inc2df92d5c-cd5a-060b-e063-6394a90aa51f2025-02-25WarningsExact identifier
unii: H0G9379FGK
Ultra Strength Antacid Assorted FruitCALCIUM CARBONATEDiscount Drug Mart, Inc2e09cb3b-cf5d-15b1-e063-6394a90a5c6a2025-02-25WarningsExact identifier
unii: H0G9379FGK
Se-Natal 19.BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM PANTOTHENATE, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE AND DOCUSATE SODIUMSeton Pharmaceuticals635104e6-6a53-4684-ac9a-7ac31b33083d2025-02-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
Extra Strength Smooth Assorted Fruit AntacidCALCIUM CARBONATEDiscount Drug Mart, Inc2df86c35-1e9b-eb49-e063-6294a90aabb62025-02-20WarningsExact identifier
unii: H0G9379FGK
Regular Strength Antacid Regular strength AntacidCALCIUM CARBONATEDiscount Drug Mart, Inc2dfa0de5-6e58-dc9d-e063-6294a90a53e02025-02-20WarningsExact identifier
unii: H0G9379FGK
Childrens Tummy ReliefCALCIUM CARBONATEGenexa Inc.f4d39d3e-82d0-2673-e053-2995a90a7d2a2025-02-20WarningsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

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