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 34 of 36 · 710 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VitrexylFOLIC ACIDPureTek Corporationae064a9e-daba-fa86-e053-2a95a90a16a72023-01-11Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
Vitranol FeFERROUS FUMARATE, FOLIC ACIDPureTek Corporationb81daf17-430b-6ba2-e053-2a95a90a768b2023-01-11Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
VitrexateFOLIC ACIDPureTek Corporationb34fee43-bea9-45b7-e053-2a95a90aad4d2023-01-11Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
Vitrexate FEFERROUS FUMARATE, FOLIC ACIDPureTek Corporationb3637def-a701-673a-e053-2995a90a02d52023-01-11Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
VenexaFOLIC ACIDPureTek Corporationba130779-cdfd-086d-e053-2a95a90a25902023-01-11Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
Venexa FEFERROUS FUMARATE, FOLIC ACIDPureTek Corporationba142128-21c4-4204-e053-2a95a90ae0d72023-01-11Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
Ribotin-EFERROUS FUMARATE, FOLIC ACIDPureTek Corporationbb1492c5-bfcd-d632-e053-2a95a90ad7d12023-01-11Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
Ventrixyl FeFERROUS FUMARATE, FOLIC ACIDPureTek Corporationc7a626ec-88ec-d899-e053-2a95a90ab0ba2023-01-11Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
Zintrexyl-CFERROUS FUMARATE, FOLIC ACIDPureTek Corporationbb1492c5-bfca-d632-e053-2a95a90ad7d12023-01-11Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
GlucoregASCORBICUM ACIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SARCOLACTICUM ACIDUM, THIAMINUM HYDROCHLORICUM, DHEA (DEHYDROEPIANDROSTERONE), PHLORIDZINUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-LIPOICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, NADIDUM, PANTOTHENIC ACID, ACETALDEHYDE, INSULINUM (SUIS), INSULINUM (HUMAN), HEPAR SUIS, PANCREAS SUIS, PHLORIDZINUM, BARYTA OXALICA, ALLOXANUM, BERBERIS VULGARIS, CARCINOSIN, LYCOPODIUM CLAVATUM, MOMORDICA BALSAMINA, PHOSPHORICUM ACIDUM, PHOSPHORUS,Deseret Biologicals, Inc.5117f980-95b8-4fc8-9425-8f6f056394372022-12-29WarningsExact identifier
unii: 88XHZ13131
EARACHE DROPSBELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFURHyland's Inc.9b18453e-e338-4b8e-9856-85aca8c46ee12022-12-12WarningsExact identifier
unii: H0G9379FGK
OSTEOBIOSCALCITONIN HUMAN - CALCIUM CARBONATE - CALCIUM FLUORIDE - CALCIUM PHOSPHATE - ISOLEUCINE - LEUCINE - LYSINE - METHIONINE - PHENYLALANINE - SUS SCROFA BONE - SUS SCROFA PARATHYROID GLAND - THREONINE - TRYPTOPHAN - VALINE -Guna spa1b8c8c83-1a46-4c0a-b883-e7dce781c5d12022-11-14WarningsExact identifier
unii: H0G9379FGK
GUNA-LYMPHOAPIS MELLIFERA - CALENDULA OFFICINALIS FLOWER - CENTELLA ASIATICA - DODECAHYDROXYCYCLOHEXANE DIHYDRATE - EQUISETUM HYEMALE - FUMARIC ACID - GOLDENSEAL - GRAPHITE - JUGLANS REGIA LEAF - LEVOTHYROXINE - MAGNESIUM PHOSPHATE - MALIC ACID - MYOSOTIS ARVENSIS - PHYTOLACCA AMERICANA ROOT - SARSAPARILLA - SODIUM DIETHYL OXALACETATE - SODIUM PYRUVATE - SUS SCROFA CAPILLARY TISSUE - SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE - SUS SCROFA VEIN - TARAXACUM OFFICINALE -Guna spaecd11761-9b9c-4d42-9e2b-f03ba4fed8ae2022-11-14WarningsExact identifier
unii: 88XHZ13131
injoy heartburn reliefFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEL. Perrigo Companyaca1b9e5-a35e-4eef-b55a-4189cd1b2a022022-09-07WarningsExact identifier
unii: H0G9379FGK
signature care acid reducer completeFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDESafeway885f43ab-5c14-417b-aab7-e887dfc48f2e2022-07-20WarningsExact identifier
unii: H0G9379FGK
Dual Action CompleteFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEKroger Company522a256b-a7c0-4783-bfff-3dc6b5a2b3152022-07-12WarningsExact identifier
unii: H0G9379FGK
Equate Acid Reducer CompleteFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEWal-Mart Stores Inc3400c3aa-15f2-4279-9623-72933298b3dd2022-07-12WarningsExact identifier
unii: H0G9379FGK
Basic Care Dual Action CompleteFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEAmazon.com Services LLC27235c87-2fe9-458f-8eb0-b9880199cd5a2022-07-11WarningsExact identifier
unii: H0G9379FGK
Bio Co-Enzyme PhaseBETA VULGARIS, ASCORBICUM ACIDUM, CYSTEINUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PULSATILLA (PRATENSIS), PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-KETOGLUTARICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CERIUM OXALICUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MAGNESIUM OROTICUM DIHYDRICUM, MALICUM ACIDUM, NADIDUM, NATRUM PYRUVICUM, PANTOTHENIC ACID, SUCCINICUM ACIDUM, ADRENALINUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, HEPAR SULPHURIS CALCAREUM, SULPHUR, ACONITICUM ACIDUM, CIS-,Deseret Biologicals, Inc.e8f6e2ec-ae2e-4bee-b9d3-5f3a2e3daf652022-05-09WarningsExact identifier
unii: 88XHZ13131
Prenatal Plus VitaminsPRENATAL WITH FERROUS FUMARATE AND FOLIC ACIDPatrin Pharma, Inc.59c5c1a4-3f42-441a-b842-903f9bab346f2022-01-13Boxed warningExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

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