FDA.reportPublic FDA data

NDC 72658-0809-05 - 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
72658-0809-05
Package NDCs from labels
72658-0809-1, 72658-0809-2, 72658-0809-6, 72658-0809-3, 72658-0809-5, 72658-0809-05
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 38 of 155 · 3,081 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cle de peau BEAUTE THE FOUNDATION N I10 VERY LIGHT IVORYOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONbeefe840-6f32-483b-8a37-2696adb8eea12026-01-05WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO SPORTS BB LIGHTOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION260a3eab-8fe6-4259-8dcc-3706ca1f68812026-01-05WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO ULTIMATE SUN PROTECTOROCTISALATE, TITANIUM DIOXIDE, OCTOCRYLENE, AND ZINC OXIDESHISEIDO AMERICAS CORPORATIONc656792a-e1ed-478d-b501-9bdc92d16eca2026-01-05WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 110 ALABASTEROCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION0a214b6b-69a7-4cb9-9095-6fcf2b6945de2026-01-05WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 430 CEDAROCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONfb6ac681-ff74-4420-a4f6-843d5f2b6d6b2026-01-05WarningsExact identifier
unii: 15FIX9V2JP
Hawaiian Blend Essential Zinc SPF 50ZINC OXIDE, TITANIUM DIOXIDEThe Islander Group47aa8605-e536-b998-e063-6394a90ad9f02026-01-05WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM NATURAL LIGHTOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONbf736c5b-fc33-4cd5-8d18-03929f739d762026-01-05WarningsExact identifier
unii: 15FIX9V2JP
CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES IVORYOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONc4028089-677f-4d51-9c8b-3892ff1649e02026-01-05WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 110OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION8a0da327-a805-4ef9-b69a-14bf7278a81a2026-01-05WarningsExact identifier
unii: 15FIX9V2JP
CLE DE PEAU BEAUTE CORRECTING VEIL nENSULIZOLE, OCTINOXATE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONfd9b42e4-6f9d-45a9-bee3-ac1bc4b352522026-01-05WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO THE MAKEUP FOUNDATION I20TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION3c024fe9-2983-4857-a55a-13406158e3a92026-01-05WarningsExact identifier
unii: 15FIX9V2JP
cle de peau BEAUTE RADIANT FLUID FOUNDATION BF10TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONb2b55a7a-1f68-429d-ba70-5bb6c7e0d8d32026-01-05WarningsExact identifier
unii: 15FIX9V2JP
TRICK AND TREAT CC2 - Active Moisturizing Color Correcting Broad-Spectrum SPF 46 PlusTITANIUM DIOXIDEHEY HONEY INC.21187805-fae9-476c-81b0-27ffeb0b99112026-01-05WarningsExact identifier
unii: 15FIX9V2JP
ParathyroparSYMPHYTUM OFFICINALE, BARYTA CARBONICA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, HEKLA LAVA, MANGANUM METALLICUM, PARATHYROID GLAND (BOVINE), RHUS TOX, SILICEAEnergique, Inc.6b098910-2f36-4757-a463-e01105340c432026-01-05WarningsExact identifier
unii: ETJ7Z6XBU4
VACC HCANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BRYONIA (ALBA), ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYOSCYAMUS NIGER, INFLUENZINUM, LEDUM PALUSTRE, MERCURIUS SOLUBILIS, MEZEREUM, NICOTINAMIDUM, HUMAN CORONAVIRUS (RNA), SENEGA OFFICINALIS, SILICEA, SPIGELIA ANTHELMIA, SULPHUR, THUJA OCCIDENTALIS, ZINCUM METALLICUMDeseret Biologicals, Inc.16d782b2-1bef-45e5-8a1d-721b1ffe56312026-01-05WarningsExact identifier
unii: ETJ7Z6XBU4
Bellas Friends Roll-on SunscreenTITANIUM DIOXIDE, ZINC OXIDEPANERGYTEK USA INC478d46ce-14e8-2231-e063-6394a90a3e272026-01-04WarningsExact identifier
unii: 15FIX9V2JP
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
PREGABALINPREGABALINEskayef Pharmaceuticals Limited65d9e751-61c2-4741-85c0-2526cfdc765c2025-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA212988
ndc (package): 72658-0813-1
ndc (package): 72658-0810-2
ndc (package): 72658-0809-2
ndc (package): 72658-0811-4
ndc (package): 72658-0811-5
ndc (package): 72658-0811-6
ndc (package): 72658-0812-5
ndc (package): 72658-0808-2
ndc (package): 72658-0814-6
ndc (package): 72658-0811-1
ndc (package): 72658-0812-2
ndc (package): 72658-0849-2
ndc (package): 72658-0809-3
ndc (package): 72658-0813-6
ndc (package): 72658-0849-1
ndc (package): 72658-0812-1
ndc (package): 72658-0812-6
ndc (package): 72658-0809-6
ndc (package): 72658-0809-1
ndc (package): 72658-0812-3
ndc (package): 72658-0814-1
ndc (package): 72658-0809-5
ndc (package): 72658-0810-3
ndc (package): 72658-0810-1
ndc (package): 72658-0808-6
ndc (package): 72658-0808-1
ndc (package): 72658-0810-5
ndc (package): 72658-0811-2
ndc (package): 72658-0813-2
ndc (package): 72658-0849-6
ndc (package): 72658-0810-6
ndc (package): 72658-0814-2
ndc (product): 72658-0810
ndc (product): 72658-0814
ndc (product): 72658-0813
ndc (product): 72658-0812
ndc (product): 72658-0808
ndc (product): 72658-0811
ndc (product): 72658-0809
ndc (product): 72658-0849
ndc11 (package): 72658080905
rxcui: 483440
rxcui: 483444
rxcui: 483442
rxcui: 577127
rxcui: 483448
rxcui: 483438
rxcui: 483450
rxcui: 483446
spl id: 4739c18b-9a48-41df-e063-6394a90a3589
spl set id: 65d9e751-61c2-4741-85c0-2526cfdc765c
unii: 55JG375S6M
Youth Glow Vitamin C CC Cream Sunscreen SPF 50 - FairOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47428cd4-fbad-ba7a-e063-6394a90a1c5c2025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Youth Glow Vitamin C CC Cream Sunscreen SPF 50 - MediumOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47433a62-91e0-b031-e063-6294a90a0d492025-12-31WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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