FDA.reportPublic FDA data

NDC 70518-3597-01 - 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
70518-3597
Requested NDC
70518-3597-01
Package NDCs from labels
70518-3597-0, 70518-3597-1, 70518-3597-2, 70518-3597-3, 70518-3597-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-08-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Pregabalin - REMEDYREPACK INC.REMEDYREPACK INC.2026-08-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3597-0Pregabalin90 in 1 BOTTLE, PLASTICCAPSULE908
70518-3597-1Pregabalin60 in 1 BOTTLE, PLASTICCAPSULE608
70518-3597-2Pregabalin90 in 1 BOTTLE, PLASTICCAPSULE908
70518-3597-3Pregabalin60 in 1 BOTTLE, PLASTICCAPSULE608

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3597PREGABALIN CAPSULE [REMEDYREPACK INC.]5Current NDC, Legacy NDC, 4 package rows20241218_12309847-0857-4ff7-a7e7-edeadc3dfb61.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3597-0EA - Each70518-3597d1f128c7-0e21-4032-9628-d267b2b46f4212026-01-08
70518-3597-1EA - Each70518-359705f433e5-ae15-499d-a974-444416d5960612026-01-08
70518-3597-2EA - Each70518-3597e26c2135-c861-4292-b7bd-4dd8ecd006e612026-01-08

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 64 of 119 · 2,367 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
toty Ilumina CC Creamy Compact Refill 1CTITANIUM DIOXIDEChipican LLCf0596830-77ed-11f0-e053-2995a90a8ff52025-09-29WarningsExact identifier
unii: 15FIX9V2JP
U V-Lamp Shield Mani-SunscreenZINC OXIDE, TITANIUM DIOXIDEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3fe7e1c3-e6cd-1420-e063-6394a90a41382025-09-28WarningsExact identifier
unii: 15FIX9V2JP
Smooth Even GlowTINTED SUNSCREEN BROAD SPF30SKNVcare, LLC3fa48151-fcb9-3d35-e063-6394a90a2eb62025-09-25WarningsExact identifier
unii: 15FIX9V2JP
SUN BUFF SPF 30 MINERAL SUNSCREENZINC OXIDE/TITANIUM DIOXIDESPF Ventures, LLC3f874062-ebab-8993-e063-6294a90abfc52025-09-24WarningsExact identifier
unii: 15FIX9V2JP
PREGABALINPREGABALINBryant Ranch Prepackca861bfb-caef-4764-bad5-c95a0d0354752025-09-23Warnings, Adverse reactionsExact identifier
rxcui: 483446
unii: 55JG375S6M
PREGABALINPREGABALINBryant Ranch Prepack0101cd1f-4a95-40e9-86a8-ccde8d656e3d2025-09-23Warnings, Adverse reactionsExact identifier
rxcui: 483440
unii: 55JG375S6M
PREGABALINPREGABALINBryant Ranch Prepack311e748a-7db4-4967-989b-5ed96871d99a2025-09-23Warnings, Adverse reactionsExact identifier
rxcui: 483438
unii: 55JG375S6M
PREGABALINPREGABALINBryant Ranch Prepackff55a40e-4a5a-40db-87b1-7ece1d5b316f2025-09-23Warnings, Adverse reactionsExact identifier
rxcui: 483450
unii: 55JG375S6M
PREGABALINPREGABALINBryant Ranch Prepack72832f05-325e-4a72-8a33-da114e39c52d2025-09-23Warnings, Adverse reactionsExact identifier
rxcui: 483448
unii: 55JG375S6M
ERBORIAN CC RED CORRECTERBORIAN CC RED CORRECT SPF 25- OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE CREAMKolmask Co., Ld.09ca2d4b-e0c2-9961-e063-6394a90aa82e2025-09-18Exact identifier
unii: 15FIX9V2JP
ELROEL Pang Pang Sun Cushion PlusZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEMONOGLOT HOLDINGS Inc.5ffaad65-f0b2-416a-b0a3-b92e880641e42025-09-18WarningsExact identifier
unii: 15FIX9V2JP
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC3f002a7f-e632-e58f-e063-6394a90abce82025-09-17Warnings, Adverse reactionsExact identifier
rxcui: 577127
unii: 55JG375S6M
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC3f00c179-336d-e534-e063-6294a90a91412025-09-17Warnings, Adverse reactionsExact identifier
rxcui: 483446
unii: 55JG375S6M
CVS SPF 50 Face SunscreenTITANIUM DIOXIDE, ZINC OXIDECVS26a69a47-947a-a478-e063-6394a90aa4682025-09-16WarningsExact identifier
unii: 15FIX9V2JP
PregabalinPREGABALINPreferred Pharmaceuticals, Inc.8ac0689e-47a3-44d7-bf98-a919c302726d2025-09-15Warnings, Adverse reactionsExact identifier
rxcui: 483446
unii: 55JG375S6M
PregabalinPREGABALINPreferred Pharmaceuticals Inc.dc50f01d-1802-4666-8f2f-35980a40990f2025-09-15Warnings, Adverse reactionsExact identifier
rxcui: 483440
unii: 55JG375S6M
PregabalinPREGABALINPreferred Pharmaceuticals, Inc.25345672-1368-4e3a-95b2-ca45fe1202942025-09-12Warnings, Adverse reactionsExact identifier
rxcui: 483440
unii: 55JG375S6M
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC3e9cfeb9-1e2b-ea79-e063-6394a90a67b12025-09-12Warnings, Adverse reactionsExact identifier
rxcui: 577127
unii: 55JG375S6M
Dry eye reliefPOLYETHYLENE GLYCOL AND PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADERf8da3af5-9172-4023-be82-0fd5bd8916162025-09-12WarningsExact identifier
unii: 6DC9Q167V3
PregabalinPREGABALINPreferred Pharmaceuticals Inc.e8e272a4-c181-4573-822b-2bb315b6ad372025-09-12Warnings, Adverse reactionsExact identifier
application number: ANDA207799
rxcui: 483438
unii: 55JG375S6M

Reported adverse events (FAERS/openFDA)#

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