FDA.reportPublic FDA data

NDC 72658-0809-01 - PREGABALIN

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
72658-0809
Requested NDC
72658-0809-01
Package NDCs from labels
72658-0809-1, 72658-0809-2, 72658-0809-6, 72658-0809-3, 72658-0809-5, 72658-0809-01
Manufacturer
Eskayef Pharmaceuticals Limited
Effective date
2025-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PREGABALIN - Eskayef Pharmaceuticals LimitedEskayef Pharmaceuticals Limited2025-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72658-0809-1PREGABALIN60 in 1 BOTTLECAPSULE609
72658-0809-2PREGABALIN90 in 1 BOTTLECAPSULE909
72658-0809-3PREGABALIN6 in 1 CARTONCAPSULE69
72658-0809-3PREGABALIN10 in 1 BLISTER PACKCAPSULE109
72658-0809-5PREGABALIN10 in 1 CARTONCAPSULE109
72658-0809-5PREGABALIN10 in 1 BLISTER PACKCAPSULE109
72658-0809-6PREGABALIN500 in 1 BOTTLECAPSULE5009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72658-0809PREGABALIN CAPSULE [ESKAYEF PHARMACEUTICALS LIMITED]8Current NDC, Legacy NDC, 7 package rows20230809_65d9e751-61c2-4741-85c0-2526cfdc765c.zip

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 25 of 157 · 3,131 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PREGABALINPREGABALINREMEDYREPACK INC.1a8f13f6-0f4c-4194-ba37-b2d1a8fc49932026-02-09Warnings, Adverse reactionsExact identifier
rxcui: 577127
unii: 55JG375S6M
Alumier MD Clear Shield Broad Spectrum SPF 42 SunscreenTITANIUM DIOXIDE, ZINC OXIDEAlumier Labsa9c970c8-b6e3-b0a1-e053-2a95a90a89c72026-02-09WarningsExact identifier
unii: 15FIX9V2JP
Droptics Performance Eye DropsNAPHAZOLINE HYDROCHLORIDE, PROPYLENE GLYCOLDroptics LLC20fd6822-a7fd-4593-92bb-0a07260893e22026-02-09WarningsExact identifier
unii: 6DC9Q167V3
Mold, Yeast and DustADRENALINUM, ARSENICUM IODATUM, ASPERGILLUS FLAVUS, ASPERGILLUS FUMIGATUS, ASPERGILLUS GLAUCUS, ASPERGILLUS NIDULANS, ASPERGILLUS NIGER, CANDIDA ALBICANS, DERMATOPHAGOIDES FARINAE, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM CLAVATUM, MUCOR PLUMBEUS, NATRUM SULPHURICUM, PENICILLIUM DIGITATUM, PENICILLIUM ROQUEFORTII, SACCHAROMYCES CEREVISIAE, SILICEANaturalCare32afa0f0-bca5-4246-bc2e-decd757fcf9d2026-02-09WarningsExact identifier
unii: ETJ7Z6XBU4
PREGABALINPREGABALINA-S Medication Solutions54a9bfb4-dcff-491d-9676-1fe1d05e004c2026-02-08Warnings, Adverse reactionsExact identifier
rxcui: 483450
unii: 55JG375S6M
PregabalinPREGABALINA-S Medication Solutions217c9f93-fe89-4684-8553-12ec9acaa5072026-02-08Warnings, Adverse reactionsExact identifier
rxcui: 483438
unii: 55JG375S6M
PregabalinPREGABALINA-S Medication Solutions5d33e9c7-6d81-485b-bf4a-9a588eda52082026-02-08Warnings, Adverse reactionsExact identifier
rxcui: 483446
unii: 55JG375S6M
Hampton Sun SPF 50 MineralZINC OXIDE 19.5% TITANIUM DIOXIDE 4.00%S&C Hampton Sun LLCd6c33436-042e-44e8-8b55-98be6e2468792026-02-06WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO WASO COLOR-SMART DAY MOISTURIZEROCTINOXATE, TITANIUM DIOXIDEShiseido Americas Corporationf291f077-1c72-48fc-bb19-c20bdeaaa5962026-02-06WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO WASO COLOR-SMART DAY MOISTURIZEROCTINOXATE, TITANIUM DIOXIDEShiseido Americas Corporation54f63dd8-e77f-42e4-a6d3-61ab7beecf502026-02-06WarningsExact identifier
unii: 15FIX9V2JP
PregabalinPREGABALINA-S Medication Solutionsfa24fa02-e27d-476a-b6c4-93650aaaee682026-02-06Warnings, Adverse reactionsExact identifier
rxcui: 483450
unii: 55JG375S6M
PregabalinPREGABALINA-S Medication Solutions55b62778-0e6a-45e8-9ace-3f1d6eca44872026-02-06Warnings, Adverse reactionsExact identifier
rxcui: 483450
unii: 55JG375S6M
SEYTU Body SunscreenTITANIUM DIOXIDE AND ZINC OXIDEOmnilife USA, Inc.c411e9a6-b2ea-446b-a886-b92c61736e6c2026-02-05WarningsExact identifier
unii: 15FIX9V2JP
SEYTU Facial SunscreenTITANIUM DIOXIDE AND ZINC OXIDEOmnilife USA, Inc.96fd37fb-c3ff-413f-b2c8-50754f320ecc2026-02-05WarningsExact identifier
unii: 15FIX9V2JP
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC99c3d252-4d51-4679-aa61-e2d0b8238b382026-02-05Warnings, Adverse reactionsExact identifier
rxcui: 483440
unii: 55JG375S6M
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 BambooOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASebfe03e7-614f-44b1-b1f1-78edc7e274cc2026-02-05WarningsExact identifier
unii: 15FIX9V2JP
DPT-TOXDROSERA, ECHINACEA, HYPERICUM, KALI MUR, MEZEREUM, SILICEA, THUJANutrition Center Inc dba Nutri-West dba Micro-West5e39f4e6-939f-4b71-9cc5-6d4b8711ea322026-02-04WarningsExact identifier
unii: ETJ7Z6XBU4
PregabalinPREGABALINAdvagen Pharma Ltd.2ffee7e7-bfa0-4933-9baf-7df55080816e2026-02-04Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
SHISEIDO URBAN ENVIRONMENT oil-free MINERAL SUNSCREEN SPF 42TITANIUM DIOXIDE AND ZINC OXIDESHISEIDO AMERICAS CORPORATION86630e82-f249-4866-82dd-3e21feb266c42026-02-04WarningsExact identifier
unii: 15FIX9V2JP
CalamineFERRIC OXIDE REDMajor Pharmaceuticalsc25be68d-834a-4959-8d47-01ec789406ba2026-02-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

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