FDA.reportPublic FDA data

NDC 52652-9001-03 - 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
52652-9001-03
Package NDCs from labels
52652-9001-1, 52652-9001-2, 52652-9001-3, 52652-9001-03
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 1 of 24 · 465 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
TopiramateTOPIRAMATEREMEDYREPACK INC.3f99b26b-79b9-4efb-aa2c-2868e1e126c82026-09-04Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: PDC6A3C0OX
QUDEXY XRTOPIRAMATEUpsher-Smith Laboratories, LLC46f54677-3a22-4c38-9b92-923020164e152026-09-03Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
topiramateTOPIRAMATEREMEDYREPACK INC.0c0a6774-e234-47a5-866e-462cfd99744c2026-09-01Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
topiramateTOPIRAMATECoupler LLC59f39dea-f29b-d6c6-e063-6294a90a5b742026-08-26Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: PDC6A3C0OX
BM BM164 DROPSARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUMBM Private Limited5902770f-eb01-d099-e063-6394a90ad3eb2026-08-14WarningsExact identifier
unii: PDC6A3C0OX
CVS GlycerinGLYCERIN SUPPOISITORYCVS Pharmacy, Incca6d13db-60e8-4fcc-b7b3-3eb280b8c4352026-08-04WarningsExact identifier
unii: PDC6A3C0OX
topiramateTOPIRAMATECoupler LLC5826cb22-3559-171b-e063-6394a90ad5942026-08-03Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
TopiramateTOPIRAMATEREMEDYREPACK INC.c90d81a9-a87b-48b0-8cf1-172b82e301272026-07-31Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
TopiramateTOPIRAMATEPD-Rx Pharmaceuticals, Inc.4833f2e8-16b7-406f-937a-55bc978bf92c2026-07-29Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
unii: PDC6A3C0OX
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: PDC6A3C0OX
TopiramateTOPIRAMATEREMEDYREPACK INC.44095c2b-2e90-45d2-ab45-d0961c41550d2026-07-20Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
topiramateTOPIRAMATEREMEDYREPACK INC.7e0834ee-920b-496f-954d-f9d81c3ba2d62026-07-17Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
TopiramateTOPIRAMATEREMEDYREPACK INC.b71c09c5-43dd-4d98-9ab6-0b0c99908cac2026-07-09Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
TopiramateTOPIRAMATEREMEDYREPACK INC.f8aaf403-0e15-4bbb-b88b-253d934396882026-07-09Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391

Reported adverse events (FAERS/openFDA)#

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