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 25 of 36 · 710 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alkums antacidCALCIUM CARBONATEGuardian Drug Company7451cd9f-1723-46d0-837e-8dc48bfb6bba2025-02-06WarningsExact identifier
unii: H0G9379FGK
Extra Strength AntacidCALCIUM CARBONATERetail Business Services, LLC.1e97c054-d6b3-425a-e063-6394a90af8362025-02-04WarningsExact identifier
unii: H0G9379FGK
Ultra Strength Antacid Assorted FruitCALCIUM CARBONATERetail Business Services, LLC.214eed56-2d35-8a69-e063-6394a90a15432025-02-04WarningsExact identifier
unii: H0G9379FGK
Ultra Strength Assorted Berry AntacidCALCIUM CARBONATEHarris Teeter, LLC2bda25ff-9e56-8f8d-e063-6294a90a6a0f2025-02-04WarningsExact identifier
unii: H0G9379FGK
Extra Strength Antacid Assorted FruitCALCIUM CARBONATERetail Business Services, LLC.1ea045ae-0b6a-47ae-e063-6394a90a35be2025-02-04WarningsExact identifier
unii: H0G9379FGK
Extra Strength Smooth AntacidCALCIUM CARBONATERetail Business Services, LLC.214eb054-b7d0-d19f-e063-6394a90a05ba2025-02-04WarningsExact identifier
unii: H0G9379FGK
Ultra Strength Antacid Assorted BerriesCALCIUM CARBONATERetail Business Services, LLC.1e987226-02fa-9c10-e063-6294a90a83bf2025-02-04WarningsExact identifier
unii: H0G9379FGK
WONDERBELLY MAXIMUM STRENGTH ANTACIDCALCIUM CARBONATEGinger Health Company2969ce5b-39ae-47b7-e063-6394a90a19092025-02-01WarningsExact identifier
unii: H0G9379FGK
Calcium Carbonate 1250 mgCALCIUM CARBONATECitraGen Pharmaceuticals, Inc.766b3f3f-8bd1-281c-e053-2991aa0af54b2025-01-30WarningsExact identifier
unii: H0G9379FGK
Calcium Carbonate 10 gr (648 mg)CALCIUM CARBONATECitraGen Pharmaceuticals, Inc.723b940d-4f4b-f2e6-e053-2991aa0a8bcc2025-01-30WarningsExact identifier
unii: H0G9379FGK
Ultra Strength AntacidCALCIUM CARBONATECVS2bc4c71c-a9c5-17df-e063-6294a90ac88c2025-01-27WarningsExact identifier
unii: H0G9379FGK
Bestmade Natural Products BM61ACID FUMARIC, APOCYNUM, BERBERIS VULG, CACTUS GRAN, ERIGERON, LYCOPODIUM , UVA URSIBestmade Natural Products2c76f996-1a85-ffe2-e063-6294a90a9f862025-01-24WarningsExact identifier
unii: 88XHZ13131
Bestmade Natural Products BM36CALCAREA CARB, CALCAREA FLUORICA, CISTUS CAN, FRAXINUS, FUCUS VES, OOPHORINUM, SECALE COR, THUJA OCCBestmade Natural Productsef2d7197-67f8-91f3-e053-2995a90a32962025-01-23WarningsExact identifier
unii: H0G9379FGK
Goodsense Ultra Strength AntacidCALCIUM CARBONATEGood Sense (Geiss, Destin & Dunn, Inc.)492deace-7ea1-4fe3-a4c7-b2c6f195d68c2025-01-20WarningsExact identifier
unii: H0G9379FGK
Calcium Carbonate 10 gr (648 mg) (Antacid)CALCIUM CARBONATE 10GR (648 MG)Ulai Health LLC641ae5b9-3bb6-41a1-ab12-367bf2fbcb0a2025-01-20WarningsExact identifier
unii: H0G9379FGK
GoodSense Extra Strength AntacidCALCIUM CARBONATEGoodSense2fcdeb06-17de-49d8-97bb-8d31e1c0c61f2025-01-20WarningsExact identifier
unii: H0G9379FGK
HEB Extra Stregth AntacidCALCIUM CARBONATEH E Bdcfe4c81-b6e0-4a9b-a521-f3ad0c0a8e482025-01-20WarningsExact identifier
unii: H0G9379FGK
Childrens AntacidCALCIUM CARBONATECVS1bf90c0c-b639-1c06-e063-6394a90ab85b2025-01-16WarningsExact identifier
unii: H0G9379FGK
Calcium Carbonate 500 mgCALCIUM CARBONATEReliable 1 Laboratories LLC322f1b54-abe9-11a7-e054-00144ff8d46c2025-01-15WarningsExact identifier
unii: H0G9379FGK
Rolaids Extra Strength MintCALCIUM CARBONATE AND MAGNESIUM HYDROXIDEChattem, Inc.604d79f3-cdfa-45e2-8c20-fa6e0ff09b2e2025-01-15WarningsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

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