FDA.reportPublic FDA data

NDC 76299-321-01 - 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
76299-321
Requested NDC
76299-321-01
Package NDCs from labels
76299-321-01, 76299-321-96, 76299-321-85, 76299-321-88
Manufacturer
Mist Pharmaceuticals, LLC
Effective date
2021-05-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Stendra - Mist Pharmaceuticals, LLCMist Pharmaceuticals, LLC2021-05-24HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
76299-321-852023-02-15These 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
76299-321-882023-02-15These 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
76299-321-962023-02-15These 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
76299-321-852023-01-30These 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
76299-321-882023-01-30These 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
76299-321-962023-01-30These 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
76299-321-852020-07-02These 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
76299-321-882020-07-02These 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
76299-321-962020-07-02These 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
76299-321-852020-01-31These 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
76299-321-882020-01-31These 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
76299-321-962020-01-31These 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76299-321-85EA - Each76299-321afabd2ea-ffbc-4328-acef-1ea2a234c3ce12017-08-11

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 21 of 36 · 710 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Acid Reducer CompleteFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEWal-Mart Stores Inccb683c1c-db81-40a9-9ec5-f8dfa0dcf8122025-07-07WarningsExact identifier
unii: H0G9379FGK
Dual Action CompleteFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEH E Bea712fc4-7f27-4556-b1b8-028f3f6ce57a2025-07-07WarningsExact identifier
unii: H0G9379FGK
DG Health acid reducer completeFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEDolgencorp, LLC95c2c515-0f31-49d9-b799-7aaded81a37c2025-07-07WarningsExact identifier
unii: H0G9379FGK
topcare dual action completeFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDETopco Associates LLC8ef70327-9a04-413b-b331-f5d3a94d6b362025-07-01WarningsExact identifier
unii: H0G9379FGK
KOSHER MEDS antacidCALCIUM CARBONATEMollec Inc7783d6a2-56e3-4542-ad1d-60680e03532b2025-07-01WarningsExact identifier
unii: H0G9379FGK
Acid Reducer CompleteFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEWalgreen Company3a456dab-0a2d-4e48-a8e2-e49a7acef9632025-07-01WarningsExact identifier
unii: H0G9379FGK
Dual Action CompleteFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEH E Bc1aa7efa-4be1-4c8f-8994-661dd60e1aa92025-07-01WarningsExact identifier
unii: H0G9379FGK
leader acid reducer completeFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDECardinal Health 110, LLC. dba Leadera5420ef1-313f-4561-baf1-7ae017ea343a2025-07-01WarningsExact identifier
unii: H0G9379FGK
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDEMorning Star OTCbe7f97d5-d2f2-45a8-96b4-fed1549ae2a32025-06-19WarningsExact identifier
unii: H0G9379FGK
Bestmade Natural Products Calcium Carbonate (Calc Carb)CALCIUM CARBONATEBestmade Natural Products2fab9f9f-ed4d-ff07-e063-6394a90a0b482025-05-26WarningsExact identifier
unii: H0G9379FGK
Kids Tummy ReliefCALCIUM CARBONATEGenexa Inc.a7831b84-1f51-9258-e053-2a95a90a901e2025-05-23WarningsExact identifier
unii: H0G9379FGK
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
NESTABS Prenatal Multi-vitamin/Mineral SupplementMULTI-VITAMIN/MINERAL SUPPLEMENT WITH SODIUM ASCORBATE, CHOLECALCIFEROL, DI-ALPHA-TOCOPHERYL ACETATE, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HCL, FOLIC ACID, CYANOCOBALAMIN, CALCIUM FORMATE, CALCIUM CARBONATE, FERROUS (II) BIS-GLYCINATE CHELATE, POTASSIUM IODIDE, ZINC OXIDE, AND CHOLINE BITARTRATEWOMENS CHOICE PHARMACEUTICALS LLC61945c85-3c9a-4b57-a8e1-79dd0469a0422025-05-13Boxed warning, WarningsExact identifier
unii: H0G9379FGK
Calcium CarbonateCALCIUM CARBONATEAtlantic Biologicals Corps38654d22-2f8a-49d2-a1cd-06d341f113232025-05-12WarningsExact identifier
unii: H0G9379FGK
Prenatal Vitamins Plus Low IronPRENATAL WITH FERROUS FUMARATE AND FOLIC ACIDA-S Medication Solutionsed793721-e869-43de-9d6e-6dc9c8230e362025-05-07Boxed warningExact identifier
unii: H0G9379FGK
Calcium CarbonateANTACIDAllegiant Health5397b702-5920-4af9-8cc5-e7fe6e2c10212025-05-01WarningsExact identifier
unii: H0G9379FGK
Caring Mill AntacidCARING MILL ANTACID CHERRY FLAVOR SOFT CHEWSXiamen Kang Zhongyuan Biotechnology Co., Ltd.2669b4f9-82c6-8a39-e063-6394a90a0fd42025-04-30WarningsExact identifier
unii: H0G9379FGK
Calcium Carbonate Antacid Assorted BerriesCALCIUM CARBONATEFSA STORE INC.e07b3ec8-c2c7-41da-8374-12fe9f09d8562025-04-18WarningsExact identifier
unii: H0G9379FGK
Rolaids Advanced Antacid Anti-gas Mixed BerryCALCIUM CARBONATE AND MAGNESIUM HYDROXIDE AND SIMETHICONEChattem, Inc.3884c05a-a593-424e-88b3-be962e73488e2025-04-10WarningsExact identifier
unii: H0G9379FGK
Kroger Wild Berry Antacid ChewsCALCIUM CARBONATEKroger326e3775-d7f9-2fd9-e063-6294a90a059b2025-04-10WarningsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

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