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 31 of 36 · 710 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equqline Regular Strength AntacidCALCIUM CARBONATEUNITED NATURAL FOODS, INC. DBA UNFIaae36cef-404b-4bb0-b107-58140c4ab8912024-04-28WarningsExact identifier
unii: H0G9379FGK
MINT ANTACID 100CALCIUM CARBONATEJHK Inc dba American Safety & First Aid2496aed6-68ec-44c4-afc9-f7fa41b2147b2024-04-24WarningsExact identifier
unii: H0G9379FGK
CirculationCACTUS GRANDIFLORUS, KALI CARBONICUM, KALMIA LATIFOLIA, ARNICA MONTANA, GLONOINUM, IGNATIA AMARA, LACTICUM ACIDUM, RANUNCULUS BULBOSUS, ALPHA-KETOGLUTARICUM ACIDUM, ARSENICUM ALBUM, FUMARICUM ACIDUM, HEART (SUIS), HEPAR SUIS, MALICUM ACIDUM, NATRUM OXALACETICUM, PHOSPHORUS, STROPHANTHUS HISPIDUS, SPIGELIA ANTHELMIA, CARBO VEGETABILIS, NAJA TRIPUDIANS, CYTOMEGALOVIRUS NOSODE, EPSTEIN-BARR VIRUS NOSODEDeseret Biologicals, Inc.29f30a6a-406d-4fb4-850d-d33486fbafe42024-04-18WarningsExact identifier
unii: 88XHZ13131
Family Wellness Ultra Stregth Antacid 171ABCALCIUM CARBONATEFamily Dollar Services, Inc.021e1a7f-8e78-4879-b101-0ddf74e2f1b72024-04-17WarningsExact identifier
unii: H0G9379FGK
Family Wellness Regular Strength Antacid 126 Regular strength AntacidCALCIUM CARBONATEFamily Dollar Services, Inc.049cce87-7ae2-4135-9c4b-7b181b24f9302024-04-17WarningsExact identifier
unii: H0G9379FGK
Multitol-MMULTIVITAMIN, FOLATEPureTek Corporation163fdc9e-a405-c3ee-e063-6294a90afd492024-04-17Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
Family Wellness Extra Strength Assorted Berry Antacid 127AB Extra strength Assorted Berry AntacidCALCIUM CARBONATEFamily Dollar Services, Inc.22aaa23b-a0a2-42cd-962a-1f76941cdac12024-04-17WarningsExact identifier
unii: H0G9379FGK
Family Wellness Extra Strength Smooth Antacid 173bfCALCIUM CARBONATEFamily Dollar Services, Inc.ee4aed8d-899e-4a27-9d95-b11151eec2982024-04-17WarningsExact identifier
unii: H0G9379FGK
FW Extra Strength AF Smooth AntacidCALCIUM CARBONATEFamily Dollar Services, Inc.e13981be-a13a-4ccd-85ce-0060db6232b22024-04-16WarningsExact identifier
unii: H0G9379FGK
Tums Chewy Bites Assorted BerriesCALCIUM CARBONATENavajo Manufacturing Company Inc.1625c724-7ead-cc70-e063-6294a90aa5582024-04-15WarningsExact identifier
unii: H0G9379FGK
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDENavajo Manufacturing Company Incac3cd760-4615-117b-e053-2a95a90a8d422024-04-15WarningsExact identifier
unii: H0G9379FGK
Gas-X Total Relief Maximum StrengthCALCIUM CARBONATE, SIMETHICONEHaleon US Holdings LLC62fc0a91-c44f-4546-a472-c183a2d954862024-04-05WarningsExact identifier
unii: H0G9379FGK
TUMS CHEWY BITESCALCIUM CARBONATE TABLET, CHEWABLELil' Drug Store Products, Inc.f67bd767-e9f1-2377-e053-2a95a90a0a2d2024-03-29WarningsExact identifier
unii: H0G9379FGK
TUMSCALCIUM CARBONATEHaleon US Holdings LLC35f79dcf-1743-4d9f-aba5-5ead6b0563092024-03-15WarningsExact identifier
unii: H0G9379FGK
TUMS extra strength, smoothiesCALCIUM CARBONATEHaleon US Holdings LLC11078d7c-373b-4c7b-b33b-f1deba613fc12024-03-14WarningsExact identifier
unii: H0G9379FGK
Tums Chewy Bites Tropical Fruit SmoothieCALCIUM CARBONATEHaleon US Holdings LLC500f821e-dd27-4c7c-b629-a826b2e57c132024-03-11WarningsExact identifier
unii: H0G9379FGK
TUMSCALCIUM CARBONATEHaleon US Holdings LLC3988e3f8-b276-43a0-bdd3-01ddd422c9862024-03-03WarningsExact identifier
unii: H0G9379FGK
TUMS SmoothiesCALCIUM CARBONATEHaleon US Holdings LLC9e54f687-4072-42fd-a14b-af67fe8b6cc42024-03-03WarningsExact identifier
unii: H0G9379FGK
Tums Regular StrengthCALCIUM CARBONATEHaleon US Holdings LLCac80f627-3f51-425b-8c75-e07363048b002024-03-03WarningsExact identifier
unii: H0G9379FGK
Tums Chewy Bites Mixed FruitCALCIUM CARBONATEHaleon US Holdings LLCd341b832-edcf-4cb2-96e1-c303b030c59a2024-03-02WarningsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

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