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 14 of 120 · 2,395 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PregabalinPREGABALINBryant Ranch Prepack025c3adb-5f6b-45f5-a4c6-cea8e57102e32026-04-07Warnings, Adverse reactionsExact identifier
rxcui: 483442
unii: 55JG375S6M
PregabalinPREGABALINBryant Ranch Prepack2ceccc4d-97e2-4eb0-841f-23609187710c2026-04-07Warnings, Adverse reactionsExact identifier
rxcui: 483446
unii: 55JG375S6M
Nu Colour Bioadaptive BB Plus Foundation - Light GoldenTITANIUM DIOXIDENSE Products, Inc.faae6f47-19f3-41cb-8e0d-388569b5c73d2026-04-07WarningsExact identifier
unii: 15FIX9V2JP
Ultra SunscreenOCTINOXATE, OCTISALATE, TITANIUM DIOXIDEJiangsu Senwo Medical Technology Co., Ltd.4ed974b8-6c11-08e0-e063-6294a90a77132026-04-07WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena MINERAL UV TINT FACE MEDIUM DEEP SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc4ee39bbf-b7d7-8f87-e063-6294a90a25392026-04-07WarningsExact identifier
unii: 15FIX9V2JP
PregabalinPREGABALINBryant Ranch Prepack247aedca-ae27-44c6-b32c-c95d264545662026-04-07Warnings, Adverse reactionsExact identifier
rxcui: 483448
unii: 55JG375S6M
PregabalinPREGABALINBryant Ranch Prepacke1ed81bc-1597-4bc5-80cd-09977a154e4b2026-04-07Warnings, Adverse reactionsExact identifier
rxcui: 483450
unii: 55JG375S6M
Nu Colour Bioadaptive BB plus Foundation - BeigeTITANIUM DIOXIDENSE Products, Inc.f74e83fe-41a0-4998-ae53-30ed5af475922026-04-07WarningsExact identifier
unii: 15FIX9V2JP
PregabalinPREGABALINBryant Ranch Prepackfd568ede-dac7-4910-bb18-65fb00f2636e2026-04-07Warnings, Adverse reactionsExact identifier
rxcui: 483438
unii: 55JG375S6M
CalamineCALAMINE 8%, ZINC OXIDE 8%Farmacias De Similares TX LLC4ecd0add-11c9-cf3b-e063-6394a90adff62026-04-06WarningsExact identifier
unii: 1K09F3G675
EltaMD Skincare UV AOX Elements SPF50 TintedTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc2c74209d-9b88-4c32-ad42-cd6de16c1fef2026-04-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV Restore TintedTITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENCP Skin Health Group, Inc4fc18856-01b3-43ed-9e1b-b4394e31aa3c2026-04-03WarningsExact identifier
unii: 15FIX9V2JP
Sunscreen for baby SPF50plusOCTOCRYLENE,ETHYLHEXYL METHOXYCINNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATEGuangzhou Senmai Biotechnology Co., Ltd.1cb7fbca-0874-ae53-e063-6294a90ab42a2026-04-02WarningsExact identifier
unii: 15FIX9V2JP
TiZO3TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD4e7bdec2-abcc-0267-e063-6394a90ae47a2026-04-02WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc17b47994-82d6-4f9d-8249-bdb55106c9b32026-04-02WarningsExact identifier
unii: 15FIX9V2JP
PregabalinPREGABALINProficient Rx LP32789571-a566-46fa-ba41-bd3c86276ecf2026-04-01Warnings, Adverse reactionsExact identifier
rxcui: 483438
unii: 55JG375S6M
Clinical Skin Filter Tinted SunscreenCLINICAL SKIN FILTER TINTED SUNSCREENBY KIN AESTHETICS LLC4e69a8a3-8dbb-577a-e063-6294a90a6a232026-04-01WarningsExact identifier
unii: 15FIX9V2JP
Krx Aesthetics All Day Glow SunblockerKRX AESTHETICS ALL DAY GLOW SUNBLOCKERBY KIN AESTHETICS LLC4e69df43-393b-bc09-e063-6394a90a275a2026-04-01WarningsExact identifier
unii: 15FIX9V2JP
spf 50 mineral powder sunscreenTITANIUM DIOXIDE, ZINC OXIDESmalls Brand LLC DBA Roe Wellnessf8762dd1-0484-74ea-e053-6294a90ac1122026-03-31WarningsExact identifier
unii: 15FIX9V2JP
PregabalinPREGABALINST. MARY'S MEDICAL PARK PHARMACY3dd7930b-f544-f18b-e063-6294a90a05412026-03-31Warnings, Adverse reactionsExact identifier
application number: ANDA207799
rxcui: 483446
unii: 55JG375S6M

Reported adverse events (FAERS/openFDA)#

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