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 81 of 119 · 2,367 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PregabalinPREGABALINAdvanced Rx of Tennessee, LLCafc8c76e-9b21-7ddb-e053-2a95a90ad7362024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 483450
unii: 55JG375S6M
Almay Smart Shade Skintone Matching Makeup LightTITANIUM DIOXIDE ZINC OXIDEAlmay, Inc.2a987b85-efdb-eb95-e063-6394a90aef812024-12-31WarningsExact identifier
unii: 15FIX9V2JP
ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20 LightTITANIUM DIOXIDE, ZINC OXIDEAlmay, Inc.2a984dd9-7293-77f0-e063-6294a90a8f1e2024-12-31WarningsExact identifier
unii: 15FIX9V2JP
PregabalinPREGABALINAdvanced Rx of Tennessee, LLCaf739a0d-a3cd-754f-e053-2a95a90ad6552024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 483448
unii: 55JG375S6M
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCd28168cd-9b7a-f8df-e053-2995a90ad97f2024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 483440
unii: 55JG375S6M
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCb8172d6b-a646-e559-e053-2a95a90ac24d2024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 483440
unii: 55JG375S6M
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCbc1b143d-feaf-9498-e053-2995a90acf502024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 483444
unii: 55JG375S6M
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCb817083c-b535-2269-e053-2a95a90af5b92024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 483438
unii: 55JG375S6M
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCc6b456ca-9d07-7789-e053-2a95a90a20c52024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 483450
unii: 55JG375S6M
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCc8bfc4f9-6208-4eaa-e053-2a95a90ada972024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 483438
unii: 55JG375S6M
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCc8acdbcf-3076-63b2-e053-2a95a90aa3c42024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 483448
unii: 55JG375S6M
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCc89a3514-f637-e54f-e053-2a95a90a68812024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA207799
rxcui: 483444
unii: 55JG375S6M
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCd2804923-a466-6dc6-e053-2a95a90a41822024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 483444
unii: 55JG375S6M
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCf5d9b625-783c-bd78-e053-2995a90a37d22024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 483438
unii: 55JG375S6M
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCf8ae62be-3a68-be6b-e053-6394a90ab6272024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 483446
unii: 55JG375S6M
Rite Aid Hydration Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLRite Aid Corporationecac1351-e944-21da-e053-2995a90a6d342024-12-31WarningsExact identifier
unii: 6DC9Q167V3
Almay Healthy Biome MakeupHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEAlmayab20969a-8640-307d-e053-2a95a90a004d2024-12-30WarningsExact identifier
unii: 15FIX9V2JP
EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUSOCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLEExelencia importers Corp.2a845e4c-86e7-1799-e063-6294a90a9b2b2024-12-30WarningsExact identifier
unii: 15FIX9V2JP
SkinCeuticals Sheer Physical UV Defense Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc2035ab03-80b4-49f4-b379-eb8bc42c9cee2024-12-30WarningsExact identifier
unii: 15FIX9V2JP
SkinCeuticals Physical Matte UV Defense Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Incb137b3d0-212b-440a-b158-62ace4b4eff32024-12-30WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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