FDA.reportPublic FDA data

NDC 52652-9001-01 - Eprontia

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
52652-9001
Requested NDC
52652-9001-01
Package NDCs from labels
52652-9001-1, 52652-9001-2, 52652-9001-3, 52652-9001-01
Manufacturer
Azurity Pharmaceuticals, Inc.
Effective date
2025-11-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Eprontia - Azurity Pharmaceuticals, Inc.Azurity Pharmaceuticals, Inc.2025-11-13Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52652-9001-1Eprontia473 mL in 1 BOTTLESOLUTION4738
52652-9001-2Eprontia1 in 1 CARTONSOLUTION18
52652-9001-2Eprontia240 mL in 1 BOTTLESOLUTION2408
52652-9001-3Eprontia1 in 1 CARTONSOLUTION18
52652-9001-3Eprontia120 mL in 1 BOTTLESOLUTION1208

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52652-9001EPRONTIA (TOPIRAMATE) SOLUTION [AZURITY PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 5 package rows20250323_e2a4df59-fead-4a01-9021-9eda02c48010.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52652-9001-1ML - Milliliter52652-90012590f13a-932d-4de9-b3c7-44eb1d1223b912021-12-08
52652-9001-2ML - Milliliter52652-9001976f39fb-48c4-457a-82b8-b9b16ff1173c12023-06-06
52652-9001-3ML - Milliliter52652-9001f3070371-41a5-4e3f-b43f-66f33163fe7312023-06-06

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 2 of 24 · 465 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopiramateTOPIRAMATEUnit Dose Solutions, Inc.562f3fec-489b-4662-e063-6294a90a4ea22026-07-09Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
topiramateTOPIRAMATEREMEDYREPACK INC.0366164b-1846-443d-9564-dbe52d8d9b652026-07-08Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
Freskaro Ear Drops for SwimmersFRESKARO EAR DROPS FOR SWIMMERSPharma Nobis, LLC4f724d85-cd38-41da-e063-6394a90a9fd72026-07-08WarningsExact identifier
unii: PDC6A3C0OX
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: PDC6A3C0OX
TopiramateTOPIRAMATEPD-Rx Pharmaceuticals, Inc.e846124d-e9e6-42c7-83f1-5df170d3f70b2026-07-07Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
TopiramateTOPIRAMATECoupler LLC55f2aca4-b961-a746-e063-6294a90ae8ce2026-07-06Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: PDC6A3C0OX
TopiramateTOPIRAMATEREMEDYREPACK INC.0cf388dc-d8f1-4478-bf5f-e64638ee58012026-06-29Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
topiramateTOPIRAMATESt. Mary's Medical Park Pharmacy92637f92-9d7c-c246-e053-2995a90a03472026-06-26Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
topiramateTOPIRAMATESt. Mary's Medical Park Pharmacy9221403c-467f-738e-e053-2995a90ac8fd2026-06-26Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd552d9018-cc7d-7e1a-e063-6294a90a33222026-06-26WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd552e16b9-f46a-7838-e063-6394a90ab8aa2026-06-26WarningsExact identifier
unii: PDC6A3C0OX
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,Energique, Inc.2e361b50-9268-4053-b13c-93af645498482026-06-25WarningsExact identifier
unii: PDC6A3C0OX
TopiramateTOPIRAMATEBryant Ranch Prepack47ef2964-3a41-4bfd-86fb-d44560b9961f2026-06-24Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
topiramateTOPIRAMATEBryant Ranch Prepack8abe45eb-cc75-4625-ae3d-5b2a038c49072026-06-24Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
TopiramateTOPIRAMATEBryant Ranch Prepack484c132f-3d3d-4218-b22f-82e9b56cc2f42026-06-24Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
topiramateTOPIRAMATEBryant Ranch Prepackbffcd213-4f09-4a5b-8ccb-591a68be402b2026-06-24Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
topiramateTOPIRAMATEBryant Ranch Prepack57462baf-2f32-4bde-9627-2214c8af93702026-06-24Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
topiramateTOPIRAMATEBryant Ranch Prepackca9ce6c1-5a60-467a-9ad5-acc7a9f8ca152026-06-24Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
topiramateTOPIRAMATEBryant Ranch Prepack12cd9be8-c5c2-4a16-9164-87963e22a88e2026-06-24Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391

Reported adverse events (FAERS/openFDA)#

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