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 19 of 36 · 710 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Unishield AntacidCALCIUM CARBONATEUnishieldb5e4d635-4c15-a849-e053-2995a90ac5612025-09-08WarningsExact identifier
unii: H0G9379FGK
Green Guard Maximum Strength Stomach ReliefCALCIUM CARBONATE 750 MGUnifirst First Aid Corporation692e09bc-2842-adb9-e053-2991aa0aec492025-09-08WarningsExact identifier
unii: H0G9379FGK
PhysiciansCare AntacidCALCIUM CARBONATEAcme United Corporation0e78664a-ccbb-4b8b-a533-a78d243f8ce82025-09-08WarningsExact identifier
unii: H0G9379FGK
Uline AntacidCALCIUM CARBONATEUline9014f295-e816-9bcd-e053-2a95a90ae1032025-09-08WarningsExact identifier
unii: H0G9379FGK
Medique Ban-acid Maximum Strength 750CALCIUM CARBONATEUnifirst First Aid Corporationa8b70bda-89be-4c1c-998b-3d97ceac9fee2025-09-08WarningsExact identifier
unii: H0G9379FGK
D-CALCALCIUM CARBONATEA&Z Pharmaceutical Inc.303bee24-d308-4b16-b382-c5f8180141172025-09-08WarningsExact identifier
unii: H0G9379FGK
topcare dual action completeFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDETopco Associates LLC2c5a1694-d6e9-4679-b421-61eaad5403a42025-09-04WarningsExact identifier
unii: H0G9379FGK
Exchange Select Antacid Soft Chews Cherry FlavorCALCIUM CARBONATEXiamen Kang Zhongyuan Biotechnology Co., Ltd.3de81025-b81c-374a-e063-6394a90a00cf2025-09-03WarningsExact identifier
unii: H0G9379FGK
Genexa Antacid Maximum StrengthCALCIUM CARBONATEPNP Pharmaceuticals Inc27fde2d4-4d49-d995-e063-6394a90ad6482025-08-31WarningsExact identifier
unii: H0G9379FGK
CareOne Acid Reducer CompleteFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEAmerican Sales Company5d4bea42-25d5-4943-b5ed-471eccd36bf82025-08-29WarningsExact identifier
unii: H0G9379FGK
D-Cal KidsCALCIUM CARBONATEAiPing Pharmaceutical, Inc.e768b861-1992-1281-e053-2a95a90a64ac2025-08-28WarningsExact identifier
unii: H0G9379FGK
Exchange Select Calcium Carbonate Antacid Smoothies Extra Strength Assorted BerriesCALCIUM CARBONATEArmy & Air Force Exchange Service3d6fbc95-5f83-a2f5-e063-6394a90a42d52025-08-28WarningsExact identifier
unii: H0G9379FGK
CareOne Acid Reducer CompleteFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEAmerican Sales Company19045840-2d25-43af-8c92-f36c8b903b282025-08-28WarningsExact identifier
unii: H0G9379FGK
Ki No SinCALCIUM CARBONATENPG Bio Pharmaceuticals Co.,Ltd.21fa2bad-5b8b-8aac-e063-6394a90a9f492025-08-27WarningsExact identifier
unii: H0G9379FGK
R CosCALCIUM CARBONATENPG Bio Pharmaceuticals Co.,Ltd.21fa767a-1344-5ed9-e063-6394a90a5fe62025-08-27WarningsExact identifier
unii: H0G9379FGK
Na Mi CalCALCIUM CARBONATENPG Bio Pharmaceuticals Co.,Ltd.20cfbcd1-eb13-933c-e063-6294a90a7e592025-08-27WarningsExact identifier
unii: H0G9379FGK
Ki No SinCALCIUM CARBONATENPG Bio Pharmaceuticals Co.,Ltd.20cf8f80-c638-4d94-e063-6294a90a54002025-08-27WarningsExact identifier
unii: H0G9379FGK
ACID REDUCER COMPLETEFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDESafeway484ad323-82cf-4157-bacb-236af8210c872025-08-27WarningsExact identifier
unii: H0G9379FGK
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MGC Health Calcium Carbonate Antacid Assorted FruitsCALCIUM CARBONATEXiamen Kang Zhongyuan Biotechnology Co., Ltd.3d4617bb-dfa8-ab8f-e063-6394a90a641b2025-08-26WarningsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

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