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 8 of 36 · 710 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kidnex IVGINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALICUM ACIDUM, PYRUVIC ACID, SUCCINICUM ACIDUM, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, GERMANIUM SESQUIOXIDE, MERCURIUS VIVUS, NUX VOMICA, KIDNEY (SUIS), LYMPH NODE (SUIS), NAPHTHOCHINONUM, NATRUM OXALACETICUM, PHOSPHORUS, URINARY BLADDER (SUIS), ACONITICUM ACIDUM, CIS-Energique, Inc.23de6b8e-7622-4ba6-89f7-37bd151687e22026-02-26WarningsExact identifier
unii: 88XHZ13131
HyVee Ultra Strength Antacid Soft Chews CherryCALCIUM CARBONATEXiamen Kang Zhongyuan Biotechnology Co., Ltd.4baa1398-515f-477d-e063-6394a90a4c942026-02-25WarningsExact identifier
unii: H0G9379FGK
FolartexMULTIVITAMINOncora Pharma, LLC0a4cb0ab-565f-45e8-a989-740bccef21cd2026-02-25Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
HyVee Ultra Strength Antacid Soft Chews CherryCALCIUM CARBONATEHy-Vee Inc4b931e41-3b61-4794-e063-6294a90aced82026-02-24WarningsExact identifier
unii: H0G9379FGK
Calcium Carbonate 500 mgCALCIUM CARBONATENuCare Pharmaceuticals,Inc.bad70158-3890-7e98-e053-2995a90a9c1c2026-02-19WarningsExact identifier
unii: H0G9379FGK
AfloraMULTIVITAMINOncora Pharma, LLC38e463d1-f608-7cb5-e063-6294a90a4abb2026-02-12Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
FolixiaMULTIVITAMINOncora Pharma, LLC413945b5-116b-d8b6-e063-6394a90a55e82026-02-12Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
NutralynMULTIVITAMINOncora Pharma, LLC33da017b-1e8c-d41c-e063-6394a90aab8c2026-02-12Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
FolatenMULTIVITAMINOncora Pharma, LLC93086235-2c33-424d-b0c3-2130319885812026-02-12Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
BIS II ToothPRECIPITATED CALCIUM CARBONATE, TOCOPHEROL ACETATE, ALUMINIUM CHLOROHYDROXY ALLANTOINATE, DIBASIC CALCIUM PHOSPHATE HYDRATEJewoo Medical CO.,LTD49e5eeaa-7506-f42a-e063-6294a90a28642026-02-03WarningsExact identifier
unii: H0G9379FGK
BIS II ToothPRECIPITATED CALCIUM CARBONATE, TOCOPHEROL ACETATE, ALUMINIUM CHLOROHYDROXY ALLANTOINATE, DIBASIC CALCIUM PHOSPHATE HYDRATEJewoo Medical CO.,LTD49f94296-3e74-1828-e063-6394a90a97d52026-02-03WarningsExact identifier
unii: H0G9379FGK
BIS II ToothPRECIPITATED CALCIUM CARBONATE, TOCOPHEROL ACETATE, ALUMINIUM CHLOROHYDROXY ALLANTOINATE, DIBASIC CALCIUM PHOSPHATE HYDRATEJewoo Medical CO.,LTD49f942e6-ceef-5505-e063-6394a90a113f2026-02-03WarningsExact identifier
unii: H0G9379FGK
LEADER Ultra Strength Peppermint FlavorCHEWABLE ANTACID TABLETSCardinal Health3bf16b23-5a67-454f-b335-677cc49cd7a32026-02-02WarningsExact identifier
unii: H0G9379FGK
Tums Chewy Bites Raspberry LemonadeCALCIUM CARBONATEHaleon US Holdings LLC3a9b6838-d450-9c3c-e063-6294a90acb622026-02-02WarningsExact identifier
unii: H0G9379FGK
Ultra Strength Antacid Assorted BerriesCALCIUM CARBONATEWAL-MART STORES INC.7cfcbb36-c84c-4dc4-873a-ae1c5204aa002026-01-30WarningsExact identifier
unii: H0G9379FGK
Assorted Fruit Antacid Flavor ChewsCALCIUM CARBONATEWalmart77ce0a54-6656-37b1-e053-2991aa0a334a2026-01-20WarningsExact identifier
unii: H0G9379FGK
Dual Action CompleteFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEMeijer Distribution Inc6e8ed233-9ffb-46f7-9632-d5bc3d3a558b2026-01-20WarningsExact identifier
unii: H0G9379FGK
Walgreen Liquid AntacidCALCIUM CARBONATE, MAGNESIUM HYDROXIDE AND SIMETHICONEWALGREENS CO.19c0d031-ee2b-47a9-9f1a-b751a61d37e52026-01-16WarningsExact identifier
unii: H0G9379FGK
Cherry AntacidCALCIUM CARBONATEWildman Business Group3e86159e-edb7-4ac2-afe5-d4b3bda3e30b2026-01-16WarningsExact identifier
unii: H0G9379FGK
Rolaids Ultra Strength Antacid StrawberryCALCIUM CARBONATE AND MAGNESIUM HYDROXIDEChattem, Inc.f4a91efc-2d81-4605-8178-d36ab6c715632026-01-14WarningsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

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